Solesta is a product for the treatment of bowel incontinence. It is a bulking agent that is injected into a part of the anal canal to improve bowel control. Solesta has been available in Europe since 2006. It was approved in the U.S. in 2011 and became available to patients beginning on September 6, 2011 through colorectal surgeon’s offices.
(Solesta was brought to market by Oceana Therapeutics. Salix Pharmaceuticals acquired all of the outstanding stock of Oceana on December 20, 2011.)
Solesta is now Fully Available in the U.S.
(September 6, 2011) Oceana Therapeutics today announced the U.S. launch of Solesta, a significant new treatment option offering patients with fecal (bowel) incontinence an opportunity for restored confidence to pursue a more normalized lifestyle.
The Food and Drug Administration (FDA) approved Solesta in May 2011 for the treatment of fecal incontinence in adult patients who fail conservative therapy (e.g., diet, fiber therapy). Solesta is an injectable gel delivered into the anal canal in an outpatient procedure taking approximately 10 minutes.
“The administration of Solesta does not involve surgery and can be performed without anesthesia” noted, John T. Spitznagel, Oceana’s Chairman & CEO. “This is a major treatment innovation for the many underserved patients faced with social embarrassment and the potential need for invasive, surgical therapies.”
David S. Tierney, MD, Oceana’s President & COO, added, “Solesta represents a powerful nonsurgical addition to the treatment arsenal of colorectal surgeons. These specialists are engaged in both noninvasive and surgical treatments of bowel incontinence, and enthusiastically welcome an entirely new treatment regime to fill the wide gap that previously existed between conservative and invasive therapies.”
FDA Approves Solesta to Treat Fecal Incontinence
The U.S. Food and Drug Administration on May 27, 2011 approved Solesta, a sterile, injectable gel to treat fecal (bowel) incontinence in patients for whom conservative therapies such as diet change, fiber therapy or anti-motility medications failed.
Fecal incontinence is the involuntary loss of bowel control. The Solesta gel is injected into a layer of tissue beneath the anus lining and may help build tissue in that area. By growing the surrounding tissue, the opening of the anus narrows and the patient may be able to better control those muscles.
“Solesta was developed in collaboration with Q-Med AB as a minimally invasive injectable gel that can be administered, relatively quickly, in an outpatient setting without the need for anesthesia," said David S. Tierney, President of Oceana Therapuetics.
The FDA based its approval on results from a clinical study of 206 patients. In the primary study, most patients received two treatments, consisting of four injections each, for a total of eight injections. After six months, more than half of the patients injected with Solesta experienced a 50 percent reduction in the number of fecal incontinence episodes. One-third of patients who received no Solesta in the study also experienced a similar reduction. Overall, a greater proportion of patients treated with Solesta experienced improvements, indicating the gel provides benefit.
Solesta is approved for use in patients ages 18 and up. It should not be used in patients who have active inflammatory bowel disease, immunodeficiency disorders, previous radiation treatment to the pelvic area, significant rectal prolapse, active infections, bleeding, tumors or malformations in the anorectal area, rectal distended veins, an existing implant in the anorectal region, or allergy to hyaluronic acid based products.
The most common side effects associated with Solesta include injection area pain and bleeding. Infection and inflammation of anal tissue are more serious risks, but are less common.
Oceana Therapeutics expects the product to be available to patients in the U.S. beginning in September 2011. Solesta® is a registered trademark of Q-Med AB of Uppsala, Sweden; Oceana Therapeutics acquired exclusive worldwide sales and distribution rights to Solesta in June 2009.
FDA Grants Approvable Letter for Solesta
On April 7, 2011 Oceana Therapeutics announced that the U.S. Food and Drug Administration (FDA) has issued an Approvable Letter for Solesta as a treatment for fecal (bowel) incontinence.
This action by the FDA means that the Solesta Premarket Approval Application is approvable subject to certain requirements having to do with labeling and manufacturing. Oceana will work with the FDA to move forward as quickly as possible for final marketing approval of Solesta.
FDA Panel Votes to Endorse Solesta to Treat Incontinence
On December 2, 2010 an FDA advisory panel voted 5-0, with one abstention, that the benefits of Solesta, a bulking agent injected into the rectum to prevent fecal incontinence, outweigh its risks. The vote by the Gastroenterology and Urology Devices Advisory Committee essentially endorses approval of the device for patients who have failed conservative therapy.
The FDA does not have to follow the advice of its committees, but it often does.
Solesta is administered as a series of four 1 mL submucosal injections in the "high pressure zone" of the patient's anal canal. It's done in an outpatient setting and does not require general anesthesia. The goal is to expand, or bulk up, the submucosal layer to improve bowel control.
Patients given Solesta also experienced a statistically significant improvement in quality of life, based on questionnaires, according to Oceana Therapeutics, the maker of Solesta.
The panel analyzed Oceana's randomized, blinded, placebo-controlled study which was conducted at eight U.S. and five European centers. Patients were between 18 and 75, had at least four episodes of fecal incontinence over the previous 14 days, and had failed some form of more conservative treatment, such as diet modification. Researchers randomized 206 patients to receive either Solesta or a sham treatment. After six months, the study was unblinded and patients on the sham treatment were offered treatment with Solesta.
Solesta was considered efficacious if incontinence episodes decreased by half; the study met that endpoint. After 12 months, 53% of Solesta patients had at least 50% fewer episodes, compared with 31% of sham patients (P<0.05). While reported adverse events included abscesses, infection, and bleeding, the panel voted 6-0 that Solesta is safe.
Application Filed for New Treatment for Incontinence
On April 12, 2010 Oceana Therapeutics and Q-Med AB announced the filing of a Premarket Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for Solesta® for the treatment of Bowel Incontinence, a largely unsatisfied medical need afflicting millions of Americans.
Solesta, which has been under development as a minimally invasive treatment for patients who have failed conservative therapy, is an injectable gel administered in an outpatient setting without the need for anesthesia. Oceana Therapeutics and Q-Med AB have collaborated on a multi-center, prospective, randomized, placebo controlled study of the product’s effectiveness and safety.
The pivotal study, representing the main body of clinical evidence in the PMA submission, involved 206 patients (136 Solesta, 70 placebo). The study consisted of a 6-month double-blinded phase followed by an open label phase in which patients originally randomized to placebo treatment were offered Solesta. The primary efficacy objective of the study required:
- demonstrating a statistically significant Solesta effect after 6 months of treatment;
- meeting a pre-defined threshold for clinical significance; and
- showing durability of the Solesta benefit up to 12 months after treatment.
All three of these endpoints were met.
Tracy Hull, MD, Professor of Surgery, Digestive Disease Institute, Colon and Rectal Surgery at the Cleveland Clinic in Cleveland OH, and a Solesta principle investigator, commented, “This is a significant medical problem that can greatly diminish a patient’s quality of life. Moreover, there is a large treatment gap between conservative therapies for fecal incontinence such as dietary control – with or without medical therapy – and more involved treatments such as surgery. Our clinical experience with this novel injectable material suggests that it may be a useful option for patients who fail conservative therapy.”
FDA approval of a PMA is required before a product can be marketed. The FDA bases a PMA approval on a determination that the application contains sufficient valid scientific evidence of safety and effectiveness for the intended use.
What are Phases?
Treatment trials or studies are in phases:
- Phase 1 tests a new drug or treatment in a small group to evaluate its safety, determine a safe dosage range, and identify side effects;
- Phase 2 expands the study to a larger group of people to see if it is effective and to further evaluate its safety;
- Phase 3 expands the study to an even larger group of people to confirm its effectiveness, monitor side effects, and collect information that will allow the drug or treatment to be used safely.