Approved by FDA 2011
Solesta™ is an effective product for the treatment of fecal incontinence, which means loss of the ability to control gases and feces, for example. Around two percent of the population suffers from the problem, above all women due to damage incurred in connection with childbirth. The product was approved for sales in Europe at the end of 2006.
In March 2011 the first randomized-controlled trial of Solesta comparing active and sham treatments showing efficacy and safety was presented. The results were published in "The Lancet". See press release
In May 2011 FDA, The U.S. Food and Drug Administration approved Solesta to treat fecal incontinence in patients for whom other therapies such as diet change, fiber therapy or anti-motility medications failed.
Salix Pharmaceuticals, Inc.
8510 Colonnade Center Drive
Raleigh NC 27615 USA