The FDA has approved Solesta gel (Oceana Therapeutics), a biocompatible tissue bulking agent consisting of dextranomer microspheres and stabilized sodium hyaluronate, for the treatment of fecal incontinence in patients ≥18 years old. Solesta is injected in the deep submucosal layer in the proximal part of the anal canal. While the exact mechanism of action has not been identified, it is believed that the Solesta injections may narrow the anal canal and allowing for better sphincter control.
The approval of Solesta was based on data from a multicenter, prospective, randomized, placebo (sham)-controlled study consisting of a 6-month double-blinded phase followed by an open-label phase in which patients originally randomized to sham treatment were offered Solesta. After six months, more than half of the patients injected with Solesta experienced a 50% reduction in the number of fecal incontinence episodes compared with one-third of patients who received no Solesta.
Solesta is expected to be made available in the third quarter of 2011.
For more information call (732) 318-3800 or visit www.solestainfo.com.