Solesta Gel:FDA Approved for Fecal Incontinence


TUESDAY, May 31 -- Solesta gel has been approved by the U.S. Food and Drug Administration to treat fecal incontinence in adults after other therapies have failed.

The sterile substance is injected into the layer of tissue beneath the anal lining. Approval was sanctioned for people in whom therapies such as modified diet, fiber therapy, or medication haven't worked, the agency said in a news release.
Loss of bowel control can result from nerve damage, muscle damage, or certain effects of aging. More than 5.5 million Americans have fecal incontinence, U.S. Government statistics show.
Solesta was evaluated in clinical studies involving 206 people. The most common side effects included injection-site pain and bleeding, and less frequently, infection and inflammation of anal tissue. The gel should not be used in people with active inflammatory bowel disease, immune disorders, or active infection, bleeding or tumors, the FDA said.
Solesta is produced by Oceana Therapeutics, based in Edison, N.J.

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