ARTICLE | Clinical News

Stendra avanafil regulatory update

September 22, 2014 7:00 AM UTC

Vivus and partner Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL, Malvern, Pa.) said FDA approved an sNDA to amend the label of erectile dysfunction (ED) drug Stendra avanafil to indicate an earlier onset of action. The label now recommends that the drug be taken as early as about 15 minutes before sexual activity, down from about 30 minutes before sexual activity.

The approval triggers a $15 milestone payment to Vivus from Auxilium, which has exclusive commercialization rights to the fast-acting phosphodiesterase-5 (PDE-5) inhibitor in the U.S. and Canada. Auxilium is merging with ophthalmic play QLT Inc. (TSX:QLT; NASDAQ:QLTI, Vancouver, B.C.) in a deal expected to close next quarter (see BioCentury, June 30). ...