Vivus and Auxilium's Stendra ED drug approved as 'on-demand' treatment in USA

The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Stendra (avanafil), developed by Vivus (Nasdaq: VVUS) and marketed in the USA and Canada by Auxilium Pharmaceuticals (Nasdaq: AUXL).

Stendra, a prescription drug cleared for EC in 2012, is now the only FDA-approved erectile dysfunction (ED) medication indicated to be taken as early as around 15 minutes before sexual activity. Vivus’ shares rose 12.9% to $4.38 in morning trading Thursday following the news.

Stendra is available in multiple dosage strengths (50mg, 100mg and 200mg tablets) and may be taken with or without food and moderate alcohol consumption (up to three drinks). In clinical studies, when compared to placebo, Stendra A helped more men achieve an erection in as early as about 15 minutes that lasted long enough to successfully complete sexual intercourse.