(SILVER SPRING, Md.) -- The U.S. Food and Drug Administration approved an injectable gel last Friday that can be used towards treating fecal incontinence in patients who have not seen results with other therapies or medications.
The gel, called Solesta and produced by Oceana Therapeutics Inc. in Edison, New Jersey, works by being injected into the tissue layer beneath the lining of the anus. Once applied, it helps tissue grow in that area, narrowing the opening of the anus and, therefore, helping patients gain better bowel control.
The FDA approved the gel after conducting a clinical study of over 200 patients. The administration found that after six months, more than half of the patients who were treated with Solesta saw a 50 percent decrease in the number of times they experienced fecal incontinence.
Although a third of the patients who weren't treated with the gel also experienced a similar reduction, the FDA reasoned that "a greater proportion of patients treated with Solesta experienced improvements, indicating the gel provides benefit."
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