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news.Oceana Therapeutics has received the US Food and Drug Administration's (FDA) approval for its sterile, injectable gel, Solesta for the treatment of fecal incontinence in patients for whom other therapies such as diet change, fiber therapy or anti-motility medications failed.
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The Solesta gel is injected into a layer of tissue beneath the anus lining and may help build tissue in that area.
The FDA approval was given on the basis of the positive results from a clinical trial involving 206 patients.
In the primary study, most patients received two treatments, consisting of four injections each, for a total of eight injections.
Following six months, more than half of the patients injected with Solesta demonstrated 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 the gel provides benefit.
FDA Center for Devices and Radiological Health director Christy Foreman said this approval provides a minimally invasive treatment option for patients with fecal incontinence that does not respond to conservative therapies.