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Quicker label for Stendra boosts Vivus

September 19, 2014 2:44 AM UTC

Vivus Inc. (NASDAQ:VVUS) gained $0.48 (12%) to $4.36 on Thursday after 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 the drug be taken about 15 minutes before sexual activity; it previously indicated Stendra for administration about 30 minutes prior.

The approval triggers a $15 million milestone payment to Vivus from partner Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL), which has exclusive commercialization rights to the fast-acting phosphodiesterase-5 (PDE-5) inhibitor in the U.S. and Canada. Vivus can receive another $255 million in milestones plus tiered royalties. ...