CORRECTED-Vivus' Stendra gets FDA approval for use 15 minutes before sex

Thu Sep 18, 2014 3:37pm EDT
 
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(Corrects headline and first paragraph to make clear that Stendra was already approved for use 30 minutes before sex, and has now been approved for use as little as 15 minutes before sex)

Sept 18 (Reuters) - The erectile dysfunction drug Stendra, currently approved by the U.S. Food and Drug Administration for use 30 minutes before sex, has now been approved for use as little as 15 minutes before sex, the drug's developers said on Thursday.

Stendra is the first FDA-approved erectile dysfunction drug that can be taken 15 minutes prior to sexual activity. The drug was developed by Auxilium Pharmaceuticals Inc and Vivus Inc.

Pfizer Inc's blockbuster erectile dysfunction drug, Viagra, can be taken about an hour before sex.

Stendra, first approved in 2012, is available in multiple dosages (50 mg, 100 mg and 200 mg tablets) and may be taken with or without food and moderate alcohol consumption (up to three drinks), the companies said on Thursday.

It belongs to a class of drugs called phosphodiesterase type 5 inhibitors, which are used to help increase blood flow to the penis.

Vivus owns the worldwide development and commercial rights to Stendra for use in sexual dysfunction, with the exception of certain Asian countries in the Pacific Rim.

Auxilium has exclusive marketing rights to Stendra in the United States and Canada, while Sanofi SA holds a license to commercialize it in Africa, the Middle East, Turkey, and the Commonwealth of Independent States including Russia.

The drug is sold as Spedra in the European Union.

Auxilium said on Wednesday it would not withdraw its offer to buy Canadian eye drug maker QLT Inc and adopted a poison pill, a day after receiving an unsolicited buyout offer from Endo International Plc. (Reporting by Natalie Grover in Bangalore; Editing by Maju Samuel)