Late-breaking news: FDA approves Solesta for fecal incontinence in adult patients

FDA has approved a sterile, injectable gel (Solesta, Oceana Therapeutics) as a treatment for fecal (bowel) incontinence in adult patients who have not responded to conservative therapy such as dietary control.

Solesta is a biocompatible tissue-bulking agent composed of dextranomer microspheres and stabilized sodium hyaluronate. Developed as a minimally invasive treatment for fecal incontinence, Solesta is injected in the deep submucosal layer in the proximal part of the anal canal and is the only injectable gel to be administered in an outpatient setting without the need for anesthesia. While the exact mechanism of action has not been identified, it is hypothesized that the Solesta injections may narrow the anal canal, allowing for better sphincter control.

“This is a significant new treatment option for the many underserved patients who fail conservative therapy and face a life of potential social humiliation and the possibility of severe invasive treatment such as surgery,” said David S. Tierney, Oceana’s president and COO, in a company press release.

According to the National Institutes of Health, there are more than 5.5 million Americans with fecal incontinence.

FDA based its approval on results from a multicenter, prospective, randomized, placebo-controlled study of the product’s effectiveness and safety. The study included 206 patients. In the primary study, most patients received 2 treatments, consisting of 4 injections each, for a total of 8 injections. After 6 months, more than half of patients injected with Solesta experienced a 50% reduction in the number of fecal incontinence episodes. However, 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 that the gel provides benefits.

Solesta should not be used by 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, distended rectal veins, an existing implant in the anorectal region, or allergy to products with a hyaluronic acid base. 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.

Solesta was developed in collaboration with Q-Med AB. Oceana Therapeutics is expected to ship and launch the product during the second half of 2011.