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.
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