BioCentury
ARTICLE | Clinical News

Flibanserin regulatory update

February 17, 2014 8:00 AM UTC

Sprout said it plans to resubmit an NDA to FDA in 3Q14 for flibanserin to treat hypoactive sexual desire disorder (HSDD) after receiving guidance from FDA. The company said FDA requested 2 additional Phase I drug interaction trials and a Phase I driving simulator study. Sprout said each study is expected to enroll about 25-50 healthy volunteers. Sprout said the guidance is the result of a formal dispute resolution filed by the company in December appealing a September complete response letter from FDA for flibanserin to treat HSDD (see BioCentury, Dec. 16, 2013). ...