May 31, 2011
Solesta Injectable Gel Approved for Fecal Incontinence
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.