Injectable Gel for Fecal Incontinence Wins FDA Approval

May 27, 2011

May 27, 2011 — The US Food and Drug Administration (FDA) today approved a sterile, injectable gel called Solesta (Oceana Therapeutics) to treat fecal incontinence in patients after other remedies have failed.

Solesta, a bulking agent, is injected just beneath the anus lining with the aim of expanding area tissue. When achieved, that expansion narrows the opening of the anus, which may help patients better control their bowel movements, according to the FDA.

The gel is approved for patients aged 18 years and older who have not been helped by diet change, fiber therapy, antimotility medications, or other therapies. It is not indicated for individuals with active inflammatory disease, previous radiation treatment to the pelvic area, and several other conditions and past treatments.

"Fecal incontinence is difficult to treat," said Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health. "This approval provides a minimally invasive treatment option for patients with fecal incontinence that does not respond to conservative therapies."

An FDA advisory panel last December recommended approval of Solesta on the basis of a clinical trial involving 206 patients in Europe and the United States. After 6 months, more than half of the patients injected with the gelexperienced a 50% reduction in the number of incontinence episodes, according to the FDA. In comparison, one third of patients who received a sham treatment had a similar reduction of episodes.

The most common adverse events associated with Solesta include pain in the injection area and bleeding, according to the FDA. Less common risks are infection and inflammation of anal tissue.

Karen Woods, MD, a member of the FDA advisory panel that issued a green light for Solesta last year, said at the time that "there was a consensus that there were no alarming adverse events, and every event that occurred was resolved or seemed to be successfully treated, and the rate is acceptable."

Solesta is already approved as an injectable treatment for fecal incontinence in Europe and Canada.

The National Institutes of Health estimates that more than 5.5 million Americans experience fecal incontinence.