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FDA Agrees to Review Updated Prescribing Information for Stendra (Avanafil)

Approval decision scheduled for September 2014 (January 21)

The FDA has accepted a supplemental application that proposes to revise the prescribing information for Stendra (avanafil, Vivus, Inc./Auxilium Pharmaceuticals) with efficacy and safety information from a randomized, double-blind, placebo-controlled evaluation of avanafil for the on-demand treatment of men with erectile dysfunction. The Prescription Drug User Fee Act (PDUFA) date for the supplemental filing is September 20, 2014.

The new study was designed to assess the efficacy of two dosage strengths of avanafil (100 mg and 200 mg) versus placebo at approximately 15 minutes after dosing in 440 patients.

Patients receiving avanafil achieved statistically significant improvements compared with placebo in the mean proportion of attempts that resulted in erections sufficient for successful intercourse as soon as 10 minutes after administration for the 200-mg dose and 12 minutes for the 100-mg dose following administration. The currently approved prescribing information recommends administration approximately 30 minutes before sexual activity.

Stendra (avanafil) is indicated for the treatment of erectile dysfunction. The drug is rapidly absorbed and should not be taken more than once per day.

Source: Vivus Inc.; January 21, 2014.

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