This page includes news on developments in drug treatments for chronic gastrointestinal illnesses. No endorsement is intended or implied.
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Developments in drug treatments for functional GI and motility disorders.
May 2023 — BOSTON and BASEL, Switzerland – May 22, 2023 – Ironwood Pharmaceuticals, Inc. (“Ironwood”) (Nasdaq: IRWD), a GI-focused healthcare company, and VectivBio Holding AG (“VectivBio”) (Nasdaq: VECT), a clinical-stage biopharmaceutical company pioneering novel, transformational treatments for severe rare gastrointestinal conditions, today announced that they have entered into a definitive agreement for Ironwood to acquire VectivBio for $17.00 per share in an all-cash transaction with an estimated aggregate consideration of approximately $1 billion, net of VectivBio cash and debt (the “Transaction”). The acquisition price represents a premium of 80% relative to the volume-weighted average share price over the previous 90 trading days. The Transaction was approved by both the Ironwood and VectivBio Boards of Directors and the Transaction Agreement was entered into on May 21, 2023. The Transaction is conditioned upon, among other things, the tender of shares representing more than 80% of VectivBio’s issued and outstanding shares and other customary conditions. Orbimed, Forbion and Versant Ventures, and VectivBio’s directors and officers, jointly representing 28.6% of VectivBio’s shareholdings, entered into tender and support agreements pursuant to which such supporting shareholders agreed, among other things, to tender their shares in the tender offer. Read the full press release here.
February 2023 — CAMBRIDGE, Mass.–(BUSINESS WIRE)–Feb. 14, 2023– Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced the publication of data from its Phase 3 ECOSPOR IV trial (ClinicalTrials.gov Identifier: NCT03183128) in JAMA Network Open that reinforce previously published results from the Phase 3 ECOSPOR III study on the investigational microbiome therapeutic SER-109 for the prevention of recurrent C. difficile infection (rCDI). With nearly 156,000 cases in the U.S., rCDI is a leading cause of hospital-acquired infection and places a significant burden on the healthcare system. See full press release here
February 2023 — LAVAL, QC / ACCESSWIRE / February 13, 2023 /Bausch Health Companies Inc. (NYSE/TSX:BHC) today announced the opening of the 2023 Salix Gastrointestinal Health Scholars Program application period. The program will award 10 exceptional students living with GI disease a scholarship of up to $10,000 as they work to pursue their higher education goals. See full press release here
February 2023 — BOSTON–(BUSINESS WIRE)– Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental New Drug Application (sNDA) for LINZESS® (linaclotide) for the treatment of children and adolescents ages 6-17 years-old with functional constipation (FC). The FDA has assigned the application a Prescription Drug User Fee Act (PDUFA) date of June 14th, 2023, four months earlier than the standard review cycle. See full press release here
January 2023 — FLORHAM PARK, N.J., Jan. 08, 2023 (GLOBE NEWSWIRE) — Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases and disorders, announced today positive topline results from PHALCON-NERD-301, a Phase 3 study evaluating the efficacy and safety of vonoprazan for the daily treatment of adults in symptomatic non-erosive gastroesophageal reflux disease (sGERD or NERD). Vonoprazan is an investigational first-in-class potassium-competitive acid blocker (PCAB) from a novel class of medicines that block acid secretion in the stomach. Full results from the study are expected later this year. See full press release here
January 2023 — OSAKA, Japan, CAMBRIDGE, Massachusetts, and Pasadena, CALIF., Jan. 9, 2023 – Takeda (TSE:4502/NYSE:TAK) and Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced topline results from the Phase 2 SEQUOIA clinical study of investigational fazirsiran (TAK-999/ARO-AAT) for the treatment of liver disease associated with alpha-1 antitrypsin deficiency (AATD-LD). The companies also provided an outline of a Phase 3 study that was co-developed by Takeda and Arrowhead and will be conducted by Takeda. Additional SEQUOIA study results are planned to be presented at a future medical meeting and submitted for publication. Arrowhead will host a webcast call for investors today, January 9, 2023, at 8:30 a.m. ET to review the Phase 2 data. Read full press release here
January 2023 — FLORHAM PARK, N.J., Jan. 03, 2023 (GLOBE NEWSWIRE) — Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases and disorders, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that no action will be taken on the Company’s new drug application (NDA) for vonoprazan, a novel potassium-competitive acid blocker (PCAB), under review as a treatment for erosive esophagitis, on or prior to the current Prescription Drug User Fee Act (PDUFA) target action date of January 11, 2023. See full press release here
December 2022 — NORTH CHICAGO, Ill., Dec. 16, 2022 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that it has submitted a supplemental New Drug Application (sNDA) for linaclotide (LINZESS®) to the U.S. Food and Drug Administration (FDA) for the treatment of children and adolescents 6 to 17 years of age with functional constipation (FC). The sNDA submission is based on results from a Phase 3 clinical trial, which met the primary and secondary endpoints, evaluating linaclotide (72 mcg) for increased frequency of spontaneous bowel movements (SBM) and improvement in stool consistency in patients aged 6 to17 years. LINZESS is developed and marketed by AbbVie and Ironwood Pharmaceuticals in the United States and is currently indicated for the treatment of adults with chronic idiopathic constipation (CIC) or irritable bowel syndrome with constipation (IBS-C). Learn more
December 2022 — SOLANA BEACH, Calif., Dec. 07, 2022 (GLOBE NEWSWIRE) — Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, today announced that the United States Patent and Trademark Office (USPTO) issued US patent No. 11,517,545 under the title “Treatment of Moderate and Severe Gastroparesis.” Read full press release here
October 2022 — FLORHAM PARK, N.J., Oct. 24, 2022 (GLOBE NEWSWIRE) — Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases and disorders, today announced it has completed enrollment in its PHALCON-NERD Daily Dosing Phase 3 trial of vonoprazan in non-erosive gastroesophageal reflux disease (NERD). Vonoprazan is an investigational first-in-class potassium-competitive acid blocker (PCAB) from a novel class of medicines that block acid secretion in the stomach. The Company expects to share topline data from the primary endpoint in the first quarter of 2023 and full results from the study in late 2023.
If successful, Phathom believes that the trial will form the basis of a supplemental New Drug Application (sNDA) for vonoprazan as once daily therapy for the treatment of symptomatic NERD in adults in 2023.
October 2022 — FLORHAM PARK, N.J., Oct. 23, 2022 (GLOBE NEWSWIRE) — Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases and disorders, announced today that detailed results from an investigational Phase 2 study evaluating the efficacy of vonoprazan in non-erosive gastroesophageal reflux disease (NERD) and other data will be presented at the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting, being held October 21-26 in Charlotte, NC. Read full press release here.
September 2022 — BOSTON, Mass.–(BUSINESS WIRE)– Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), today announced positive topline data from a Phase III clinical trial evaluating LINZESS (linaclotide) 72 mcg in pediatric patients aged 6-17 with functional constipation (FC). The trial met its primary and secondary endpoints, demonstrating that linaclotide (72 mcg) improved frequency of spontaneous bowl movements (SBM) and stool consistency. Linaclotide was generally well-tolerated, and the safety profile is consistent with previously reported studies with linaclotide in FC and irritable bowel syndrome (IBS) in pediatric patients. See full press release here
September 2022 — CAMBRIDGE, Massachusetts, September 14, 2022 Takeda (TSE:4502/NYSE:TAK) today announced the national launch of the CDPATHTM program, which includes an innovative, validated personalized prognostic tool that uses blood tests† to help predict the potential risk of developing serious Crohn’s disease-related complications within three years.1,2 CDPATH is available for use by US-based physicians and offered at no cost to eligible patients††, providing an opportunity for patients to partner with their physicians to map out a personalized disease management plan.
CDPATH is for adult patients (≥18 years old) diagnosed with Crohn’s disease (CD) within the past 10 years who have yet to experience serious complications defined as bowel strictures, internal penetrating disease, or non-perianal surgery (bowel resection or stricturoplasty).1,2 Patients can have blood drawn for the CDPATH test at one of more than 2,500 participating locations nationwide. Read the full press release here
August 2022 — SOLANA BEACH, Calif., Aug. 01, 2022 (GLOBE NEWSWIRE) — Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced their ongoing collaboration with the International Foundation for Gastrointestinal Disorders (IFFGD) for Gastroparesis Awareness Month celebrated in August each year. Alongside the IFFGD, Evoke and EVERSANA’s goal for the month is to help improve general understanding and awareness of gastroparesis to help patients and families manage the condition. See full press release here
August 2022 — CAMBRIDGE, Mass., Aug. 31, 2022 /PRNewswire/ — Kiwi Biosciences, the Y Combinator-funded biotech startup making food painless, launches the next generation FODZYME®, a novel patent-pending enzyme supplement helping people enjoy their favorite foods, wherever they are. Low-FODMAP certified by Monash University, FODZYME breaks down common gut symptom triggers found in garlic, onion, wheat and other popular foods. These compounds, called FODMAPs, are particularly problematic for people with Irritable Bowel Syndrome (IBS), which affects 15% of the global population. See full press release here.
June 2022 — Auckland, New Zealand, Wednesday 15 June, 2022. Alimetry, a medical device and digital healthcare company, today announced it has received US Food and Drug Administration (FDA) clearance for Gastric Alimetry, a pioneering non-invasive medical device for aiding the diagnosis gastric disorders. Alimetry also announced today the launch of Alimetry Inc., a subsidiary based in Minneapolis, MN, that will market and distribute Gastric Alimetry in the United States.
June 2022 — CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jun. 13, 2022– Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) approved AMVUTTRA™ (vutrisiran), an RNAi therapeutic administered via subcutaneous injection once every three months (quarterly) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. hATTR amyloidosis is a rare, inherited, rapidly progressive, and fatal disease with debilitating polyneuropathy manifestations, for which there are few treatment options. The FDA approval is based on positive 9-month results from the HELIOS-A Phase 3 study, where AMVUTTRA significantly improved the signs and symptoms of polyneuropathy, with more than 50 percent of patients experiencing halting or reversal of their disease manifestations. View the full release here.
April 2022 — Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, today announced the launch of IBSRELA, the first and only NHE3 inhibitor for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. IBSRELA is the first FDA-approved product for Ardelyx. View the press release here. You can also view the Full Prescription Information, including the box warning here.
February 2022 — Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on Gimoti (metoclopramide) nasal spray (GIMOTI), today announced that the results of a retrospective analysis of United States (US) administrative claims data that examined the association between tardive dyskinesia (TD) and potential risk factors will be presented at the annual Digestive Disease Week Meeting in San Diego, CA taking place from May 21-24, 2022.
Selected as a poster of distinction during DDW 2022, the presentation titled: “Revisiting the Risk of Tardive Dyskinesia with Metoclopramide Use: A Real-World Data Driven Epidemiology Study From 2011-2021” will cover the data analytics of an 80 million patient database (Truven Health MarketScan®) used to conduct the most comprehensive analysis to date on the risk of metoclopramide-induced tardive dyskinesia. In the limited literature available, the reported incidence of TD varies widely.
Details of the poster presentation are as follows:
Session Title: Gastroparesis and Small Intestinal Dysmotility
Presentation Title: “Revisiting the Risk of Tardive Dyskinesia with Metoclopramide Use: A Real-World Data Driven Epidemiology Study From 2011-2021”
Date: May 21, 2022
Time: 12:30 p.m. – 1:30 p.m. PDT
Location: San Diego Convention Center
December 2021— BOSTON (December 8, 2021) Next-Generation Cellvizio delivers real-time, in vivo cellular imaging to address growth in life-threatening, high-cost disease states. A timely, accurate diagnosis is the difference between life and death for millions of people who are diagnosed with complex conditions like cancer, respiratory disease, and gastrointestinal disease. As the occurrence of these conditions continues to grow, the ability to quickly and accurately deliver a diagnosis and determine the best course of treatment is more important than ever. Cellvizio® from Mauna Kea Technologies supports this need with the only confocal laser endomicroscopy (CLE) device that allows physicians to see real-time cellular activity virtually anywhere in the human body. Mauna Kea Technologies, which has received 19 U.S. FDA 510(k) clearances for its technology, achieved its most recent FDA clearance for its Next-Generation Cellvizio platform in August 2021. Cellvizio has proven to be effective in diagnosing and informing the treatment of deadly diseases like lung cancer, pancreatic cysts, and esophageal cancer (EAC); as well as functional conditions such as irritable bowel syndrome (IBS), and food intolerance.,, Cellvizio has also been cleared for use in a range of procedures, including gastrointestinal endoscopy, bronchoscopy, surgical and robot-assisted procedures. For more information, visit www.maunakeatech.com.
September 2021 — Azurity Pharmaceuticals is recalling one lot of Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit because some products in the affected lot have been found to incorrectly contain a First Omeprazole (FIRST-PPI) diluent instead of the Firvanq diluent bottle. Vancomycin may not be completely solubilized in the FIRST-PPI diluent which could lead to doses above or below those recommended in the label. There is reasonable probability that the administration of inappropriate doses of oral vancomycin may lead to persistent diarrhea associated with dehydration and electrolyte abnormalities, recurrence of Clostridium difficile (C. difficile) infection, its progression to severe colitis, colon perforation requiring colectomy, and potentially death. Especially, the elderly and immunocompromised patients are vulnerable to the complications of C. difficile infection. Read recall here.
July 2021 — LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests by Magellan Diagnostics: Class I Recall – Due to Risk of Falsely Low Results. Magellan Diagnostics, is recalling its LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests due to a significant risk of falsely low results. The FDA has significant concerns that the performance of the test may provide falsely low results and may lead to health risks in special populations such as young children and pregnant individuals. A pregnant or lactating individual’s exposure to lead is concerning because it not only may cause health problems for the parent but can result in lead exposure to the developing baby. Obtaining falsely low results may lead to patient harm including delayed puberty, reduced postnatal growth, decreased IQ, and inattention and behavior problems in children. Read recall here.
June 22, 2021 — Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, and EVERSANA™, a leading provider of global commercial services to the life science industry and The International Foundation for Gastrointestinal Disorders’ (IFFGD), today announced its membership into IFFGD Industry Council. Evoke will join a likeminded group of organizations and brands focused on bettering patients affected by gastrointestinal disorders. As part of the Industry Council, Evoke will participate in bi-annual council meetings to gain industry insights and provide feedback on future plans for IFFGD.
In addition to the Industry Council, Evoke is excited to sponsor the IFFDG’s upcoming 30th Anniversary Digestive Health Virtual Walk in August during Gastroparesis Awareness Month. This walk is a unique fitness event which will provide participants with an opportunity to engage at their own pace and as their health and schedules permit. To honor the thirty years of the IFFGD’s existence, the overall campaign goal is for all participants to collectively walk 10,950 miles over two weeks. Goals will also go beyond physical fitness by encouraging participants to participate in activities that promote general wellness such as scheduling a doctor’s appointment, trying a new gut friendly recipe or starting a log of their meals and/or symptoms.
June 22, 2021 — Mauna Kea Technologies (Euronext: MKEA) inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announces a peer-reviewed publication in the journal Nature Scientific Reports entitled “Cross-sectional imaging of intestinal barrier dysfunction by confocal laser endomicroscopy can identify patients with food allergy in vivo with high sensitivity” (2021, https://www.nature.com/articles/s41598-021-92262-4). This paper provides new evidence that Cellvizio®, thanks to its unique capability to perform real-time functional imaging in vivo and at the cellular level, can accurately diagnose patients with food allergies. Learn more.
June 15, 2021 — ATLANTA, June 15, 2021 /PRNewswire/ — ModifyHealth, together with Monash University, Australia, announce a partnership that will seek to raise further awareness in the US of the FODMAP diet protocol and the Monash University FODMAP Diet App, which have helped millions of people manage irritable bowel syndrome (IBS). The partnership will increase engagement with US consumers and healthcare providers, and expand awareness of the latest research and developments of the FODMAP diet protocol. Learn more
June 14, 2021 — Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage biotechnology company focused on rare and unmet needs in gastroenterology, announced today the initiation of its Phase 2 trial of vurolenatide, a proprietary long-acting glucagon-like peptide-1 (GLP-1) agonist in adults with short bowel syndrome (SBS). The Phase 2 trial, known as the VIBRANT (VurolenatIde for short Bowel syndrome Regardless of pArenteral support requiremeNT) study, is a double-blind, multicenter, placebo-controlled parallel group study of the safety, efficacy and tolerability of vurolenatide in adult patients with short bowel syndrome. Read more about this phase 2 study here.
June 2021 —Viona Pharmaceuticals Inc., is voluntarily recalling 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. The 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg have been found to contain levels of Nitrosodimethylamine (NDMA) impurities above acceptable daily limits. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India in November 2019, for U.S. distribution by Viona Pharmaceuticals Inc. Read more about this recall here.
May 31, 2021 — BOSTON–(BUSINESS WIRE)– Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI-focused healthcare company, presented new findings at the Digestive Disease Week® (DDW) 2021 virtual meeting from a survey highlighting disease burden and care-seeking behavior among adult patients with irritable bowel syndrome with constipation (IBS-C) during the COVID-19 pandemic.
The poster presentation, titled Disease Burden and Care-Seeking Behavior for IBS-C Patients in the United States in the Era of COVID-19(presentation number Fr014), summarized data from a cross-sectional online general health survey of 130 adults with IBS-C conducted from August through October 2020. More than a third of surveyed IBS-C patients indicated their symptoms had worsened during the COVID-19 pandemic. Additionally, nearly a quarter reported cancelling healthcare visits due to COVID-19. Also, nearly half (46%) of surveyed IBS-C patients reported that they did not seek care from a healthcare provider in the past year for their symptoms.
“As a physician, my biggest takeaway from this survey is that while IBS-C patients’ symptoms have been exacerbated during the COVID-19 pandemic, they are unfortunately not speaking with their doctors, and hence the disease continues to have a wide impact despite availability of prescription treatment options,” said Brian E. Lacy, M.D., Ph.D., Gastroenterology, Neurogastroenterology, the Mayo Clinic. “It is critical for patients to recognize they have a legitimate medical condition that needs treatment and to take that step of speaking with their physician – either in person or through a telehealth appointment.”
Other key findings from the survey, which was conducted in collaboration with researchers from the Mayo Clinic, the Acumen Health Research Institute and the International Foundation for Functional Gastrointestinal Disorders, include:
- Surveyed IBS-C patients reported a significantly higher proportion of moderate-to-severe anxiety and depression and significantly lower health-related quality of life (HRQoL) than surveyed patients without IBS-C.
- Absenteeism and presenteeism were also significantly higher among surveyed IBS-C patients versus those without IBS-C.
- 25% of surveyed IBS-C patients reported currently taking a prescription medication whereas 68.5% reported currently taking an OTC for their IBS-C symptoms.
- Most common bothersome symptoms in the past seven days included abdominal discomfort, abdominal pain, straining, abdominal bloating and incomplete bowel movements.
May 20, 2021 — During this year’s Digestive Disease Week (DDW) annual meeting, Takeda Pharmaceuticals presented data from several studies of Entyvio® (vedolizumab), including real-world data from the EVOLVE study and GEMINI 2 post-hoc analyses in patients with Crohn’s disease (CD). For more details, please see the two presentations below:
- Real-World Effectiveness of First-Line Biologic Vedolizumab in Crohn’s Disease: Analysis of Higher Treatment Effect Subpopulation from the EVOLVE Study1 – Presentation 22
- The aim of this analysis was to identify a subpopulation of biologic therapy-naïve patients with CD for whom vedolizumab would have a larger treatment effect versus anti-tumor necrosis factor-α (anti-TNFα) therapies for the outcome of clinical remission. Data was analyzed from EVOLVE, a multi-country, retrospective cohort study of patients with inflammatory bowel disease (IBD) who initiated first-line biologic treatment with vedolizumab or anti-TNFα therapy.i
- Results from the EVOLVE study were also recently published in The Journal of Crohn’s and Colitis.
- Symptomatic Improvement with Vedolizumab Therapy for Crohn’s Disease Stratified by Disease Activity and Prior Tumor Necrosis Factor Antagonist Failure: Post Hoc Analyses from the GEMINI 2 Trial2 – Presentation Sa083
- The aim of this analysis was to investigate symptomatic improvement, including onset of action, across disease activity and prior anti-TNFα status in patients with CD from the GEMINI 2 phase 3, randomized, placebo-controlled clinical trial of vedolizumab treatment for moderate to severe CD. ii
May 17, 2021 — Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD), a GI-focused healthcare company, today announced that the company and its collaborators will present seven posters- four of which have been named posters of distinction- during the Digestive Disease Week ® (DDW) 2021 Virtual Meeting. Two posters of distinction will discuss the impact of linaclotide on visceral hypersensitivity, one of the main underlying causes of irritable bowel syndrome with constipation (IBS-C). Other data will discuss disease burden and care-seeking behavior among patients with IBS-C during the COVID-19 pandemic. Additional posters will reveal data from a GI disease survey of nearly 90,000 Americans.
April 12, 2021 — 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage company focused on rare and unmet needs in gastroenterology, announced today that the Company will collaborate with the Celiac Disease Foundation (CDF) to support clinical trial enrollment in 9 Meters’ Phase 3 study, CeDLara, for their drug candidate larazotide in celiac disease. Learn more
February 10, 2021 — Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that it has submitted an application to the Japanese Ministry of Health, Labour and Welfare to manufacture and market darvadstrocel (development code: Cx601) for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease (CD).
January 31, 2020 — The US Food and Drug Administration (FDA) has approved Dificid (fidaxomicin) tablets and oral suspension for the treatment of pediatric patients with Clostridioides difficile (C. difficile), a bacterium that causes diarrhea and colitis. For more information, please see here.
February 10, 2020 — Palette Life Sciences, Inc., a medical device company dedicated to assisting healthcare professionals (HCPs) to improve patient outcomes in colorectal urologic and oncologic conditions and diseases, today announced the launch of the Solesta® Reimbursement Assistance Program. Solesta is a minimally-invasive, and easily injectable viscous gel made from two polysaccharides, Non-Animal Stabilized Hyaluronic Acid (NASHA®) and Dextranomer (Dx) microspheres.1 Solesta is the only quick, nonsurgical treatment for fecal incontinence, administered in an outpatient setting without the need for anesthesia.2 HCPs can simply follow three steps at MySolesta.com to become trained in Solesta administration and technique. Studies have shown that Solesta can help patients return to a more active lifestyle (socializing, going to work, etc.) and reduces the depression and embarrassment that is often associated with bowel control problems.
February 13, 2020 — The US Food and Drug Administration (FDA) has approved a new treatment for chronic idiopathic constipation (CIC). The approval allows Braintree Laboratories to move forward with lactitol (Pizensy), an osmotic laxative indicated for the treatment of CIC in adults for a recommended dosage of 20 grams orally daily.
February 14, 2020 — Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced results from the phase 3 VISIBLE 2 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the gut-selective biologic vedolizumab (Entyvio®) for use during maintenance therapy in adult patients with moderately to severely active Crohn’s disease (CD). The study evaluated patients who achieved clinical response* at week 6 following two doses of open-label vedolizumab intravenous (IV) induction therapy at weeks 0 and 2. The results show that at week 52, significantly more patients on vedolizumab SC compared to placebo were in clinical remission (48.0% [n=132/275] vs. 34.3% [n=46/134] respectively; [p=0.008]),** meeting the study’s primary endpoint.1 These data were announced during an oral presentation at the 15th Congress of the European Crohn’s and Colitis Organisation (ECCO) in Vienna, Austria.
February 25, 2020 — WASHINGTON/PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq:VNDA) today announced results from a Phase III clinical trial (EPIONE) of tradipitant for the treatment of pruritus in atopic dermatitis (AD) in adults. The EPIONE study did not meet its primary endpoint in reduction of pruritus across the overall study population. However, the antipruritic effect of tradipitant was robust in the mild AD study population. Mild AD represents over 60% of the total AD population in the U.S.1, 2 The EPIONE study continued to demonstrate that tradipitant is safe and well-tolerated.
March 9th, 2020 — TEL-AVIV, Israel and RALEIGH, N.C., RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company focused on gastrointestinal diseases, today announced the U.S. commercial launch of Talicia® (omeprazole magnesium, amoxicillin and rifabutin)1 delayed-release capsules 10 mg2/250 mg/12.5 mg for the treatment of Helicobacter pylori (H. pylori) infection in adults. RedHill’s expanded U.S. sales force will promote Talicia® nationwide to approximately 25,000 gastroenterologists, primary care physicians and other healthcare providers.
March 24, 2020 — FDA is informing health care providers and patients of the potential risk of transmission of SARS-CoV-2 virus by the use of fecal microbiota for transplantation (FMT) and that FDA has determined that additional safety protections are needed.
Several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals. This information suggests that SARS-CoV-2 may be transmitted by FMT, although the risk of such transmission is unknown. At this time, testing nasopharyngeal specimens from stool donors for SARS-CoV-2 may not be widely available. Furthermore, there is limited information on the availability and sensitivity of direct testing of stool for SARS-CoV-2.
As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted.
April 1, 2020 — The U.S. Food and Drug Administration today announced it is requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.
“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”
April 15, 2020 – The U.S. Food and Drug Administration has announced that Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. This recall is due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA. Read the full announcement here.
April 16, 2020 – The U.S. Food and Drug Administration Center for Drug Evaluation and Research (CDER) announced approval today of Drug Safety-related Labeling Changes for Movantik (NALOXEGOL OXALATE). These changes were made to the Warnings and Precautions, and Adverse Reactions. Read the labeling changes here.
April 28, 2020 – The U.S. Food and Drug Administration has announced that GSK Consumer Healthcare is voluntarily recalling specific lots of Benefiber Healthy Shape Prebiotic Fiber Supplement powder and Benefiber Prebiotic Fiber Supplement powder due to possible plastic contamination from the bottle cap. Read the full announcement, including lot numbers, here.
May 15, 2020 – Today, the U.S. Food and Drug Administration approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST), a type of tumor that originates in the gastrointestinal tract. Qinlock is indicated for adult patients who have received prior treatment with three or more kinase inhibitor therapies, including imatinib. Read more here.
June 19, 2020 – SOLANA BEACH, Calif., (GLOBE NEWSWIRE) — Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for GIMOTI™ (metoclopramide) nasal spray, the first and only nasally-administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. For more information, visit here.
July 13, 2020 – Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) announced today that the U.S. Food and Drug Administration (FDA) has authorized a single patient in an Individual Patient Expanded Access protocol (VP-VLY-686-3303). This patient had previously participated in a randomized study of tradipitant in gastroparesis for 12 weeks. The patient and treating physician requested expanded access to continue treatment beyond 12 weeks, as the treating physician had judged that tradipitant was the only treatment that effectively managed the patient’s gastroparesis symptoms. For more information, visit here.
July 28, 2020 – TEL AVIV, Israel and RALEIGH, NC, RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced the publication of data from its previously announced Phase 2 study of RHB-102 (Bekinda®)1, a novel, proprietary, once-daily, 12mg bimodal-release ondansetron, in diarrhea-predominant irritable bowel syndrome (IBS-D), in The American Journal of Gastroenterology.
Aug 7, 2020 – Today, the U.S. Food and Drug Administration approved Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate. Olinvyk is indicated for short-term intravenous use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures. It is not indicated for at-home use. Here you can read more.
September, 2020 – The New Digital Care App to Effectively Manage IBS by Regulating the Gut-Brain Connection- Zemedy is the world’s first evidence-based programme that uses CBT digitally to restore gut-brain connection and help IBS sufferers. A trial V1 of the app was launched in 2019 where it was reported that users experienced a significant reduction in symptoms, some with no flareups at all. Zemedy is from Bold Health, an organisation that creates digital care tools for digestive health. Chronic digestive problems are common and often connected to poor mental wellbeing. Therefore, through its digital applications, Bold Health provides patients with constant access to cognitive behavioural therapy programmes designed for their specific condition.
May 17, 2019 — The US Food and Drug Administration (FDA) has approved an extended indication for the drug teduglutide in pediatric patients one year and older with short bowel syndrome (SBS). Teduglutide was originally approved for use in adults with SBS in 2012.
April 5, 2019 — Following approval by the US Food and Drug Administration (FDA) last year, Takeda Pharmaceuticals has announced that prucalopride (Motegrity), a once-daily, oral treatment for adults with chronic idiopathic constipation (CIC), is now commercially available by prescription in the US.
April 2, 2019 — The US Food and Drug Administration (FDA) has approved the reintroduction of tegaserod (Zelnorm), a twice-daily oral treatment for irritabble bowel syndrome with constipation (IBS-C) in women under 65, following a complete safety review.
February 18, 2019 — A new treatment for fecal incontinence in individuals with spinal cord injury (RDD-0315) was given fast track designation by the US Food and Drug Administration. “Fast track” is a type of designation given by the FDA to expedite the review of investigational therapies which treat a serious or life-threatening condition and fill an unmet medical need.
January 18, 2019 — The National Medical Products Administration (NMPA) has approved linaclotide (Linzess) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) in China.
December 21, 2018 — The US Food and Drug Administration (FDA) has approved an app (InterStim smart programmer) that assists patients using the InterStim system, a therapy providing sacral neuromodulationfor the treatment of overactive bladder or chronic bowel incontinence. The app allows individuals with the InterStim system to manage their treatment at home and gives physicians greater personalization of care.
December 17, 2018 — The US Food and Drug Administration (FDA) has approved prucalopride (Motegrity), a once-daily, oral treatment option for adults with chronic idiopathic constipation (CIC).
December 6, 2018 — Health Canada has approved the antibiotic rifaximin (Zaxine) for the treatment of adults with irritable bowel syndrome with diarrhea (IBS-D) in Canada.
December 6, 2018 — Positive Phase II study results were announced for tradipitant for the treatment of gastroparesis. The drug met the primary endpoint of the study (reduced nausea) and was found to be well tolerated compared with placebo.
December 4, 2018 — The European Commission has granted Orphan Drug Designation to apraglutide for the treatment of short bowel syndrome (SBS). This designation is granted to therapies intended to treat serious rare conditions affecting no more than five in 10,000 persons in the European Union and for which either no satisfactory treatment currently exists or the proposed therapy would provide a significant benefit to those affected compared with existing therapies.
November 21, 2018 — Nestlé Health Sciences has partnered with Entrinsic Health Solutions on enterade, an electrolyte beverage designed to help address hydration issues in individuals with gastrointestinal (GI) issues related to cancer or chronic GI illness.
November 19, 2018 — The US Food and Drug Administration (FDA) has accepted the filing of a new drug application (NDA) for extended use of teduglutide injection in children aged 1 to 17 years with short bowel syndrome (SBS). Teduglutide is currently approved for adults with SBS who are dependent on parenteral nutrition.
November 19, 2018 — The US Food and Drug Administration (FDA) approves antibiotic rifamycin (Aemcolo) for the treatment of adults with traveler’s diarrhea caused by non-invasive strains of Escherichia coli (E. coli).
Treatment News Presented at ACG 2018
In October 2018, IFFGD gathered with clinicians, researchers, drug developers and manufacturers, and others at the American College of Gastroenterology (ACG) annual meeting in Philadelphia, PA to get the latest research updates in the field of digestive health. Major medical meetings, like ACG, present companies with an opportunity to share news on developments in drug treatments. Here are a selection of drug developments announced at ACG this year:
- Long-term safety data was presented for the drug tenapanor for irritable bowel syndrome with constipation (IBS-C). In several previous Phase III trials, tenapanor was found to effectively reduce constipation and abdomial pain in patients with IBS-C. The most common side effect of the drug is diarrhea (9.2%).
- Clinical data showing improvement in health-related quality of life and the effects on esophageal erosions were presented for IW-3718 for the treatment of persistent gastroesophageal reflux disease (GERD). Persistent GERD is defined as the persistent occurrence of heartburn and regurgitation despite standard treatment of proton pump inhibitors (PPIs). Phase III clinical trials are currently undergoing to assess the safety and effectiveness of IW-3718.
- Safety and efficacy data were presented for plecanatide for the treatment of IBS-C and chronic idiopathic constipation (CIC) in patients 65 years and older compared with patients younger than 65 years. Safety (adverse event and discontinuation rates) and efficacy were consistently demonstrated between the two populations.
- Results of a two year follow-up study confirm safety and tolerability of a novel delivery of peppermint oil for the dietary management of IBS. The most common self-reported side effects were abdominal pain/discomfort/distension, diarrhea, and dyspepsia.
- Safety and effeicacy data were presented for eluxadoline in patients with IBS with diarrhea (IBS-D) who reported inadequate symptom control with over-the-counter (OTC) loperamide. Eluxadoline is not indicated for patients without a gallbladder.
- Overall safety and tolerability data were presented for the drug relamorelin for the treatment of adults with diabetic gastroparesis.
- The availability of a new blood test for the diagnosis of IBS-D (detects elevated levels of Cyolethal distending toxin B (CdtB) and anti-vinculin in blood) was announced.
- A two-week course of rifaximin was found to improve abdominal pain and bloating symptoms in adults with IBS-D.
- Improved bowel regularity, symptom improvement, and patient satisfaction were reported for a new prebiotic fiber supplement for generalized constipation.
September 18, 2018 — Teduglutide has been approved in South Korea by the Ministry of Food and Drug Safety for the treatment of short bowel syndrome (SBS).
September 18, 2018 — Linaclotide (Linzess) has been approved in Japan for the treatment of adult patients with chronic constipation.
September 18, 2018 — The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) for an investigational nasal spray formulation of metoclopramide (Gimoti) for the treatment of adult women with acute or recurrent diabetic gastroparesis.
December 16, 2015 — The new FDA approved drug, eluxadoline (Viberzi), is available for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in men and women.
Drug Safety-related Labeling Changes