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FDA Okays 15-minute Erectile Dysfunction Drug

Update Date: Sep 18, 2014 02:57 PM EDT
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A fast acting drug for erectile dysfunction recently received approval for use in United States from the Food and Drug Administration.

Reuters reported that the drug Stendra belongs to a class of drugs known as phosphodiesterase type 5 inhibitors which work by increasing blood flow to penis. The drug was developed in 2012 by Auxilium Pharmaceuticals Inc. and Vivus Inc. It can be taken 15 minutes before sexual activity.

In comparison, Pfizer's Viagra, more popularly known as the blue pill and a standard prescription for men with erectile dysfunction, is recommended for use an hour before intercourse.

In a statement announcing FDA approval on Thursday, Vivus and Auxilium said Stendra is the first FDA ED approved drug to come by in a decade.

"Stendra offers men and their partners an exciting new option. We believe this label expansion helps position Stendra as an exciting 'on demand' ED treatment and assists with the very important aspect of spontaneity for men and their partners in real world use. We believe this provides a meaningful benefit for men with ED and further underscores Auxilium's commitment to being an innovative leader in men's healthcare," said Adrian Adams, Chief Executive Officer and President of Auxilium Pharmaceuticals.

Stendra is available in 50 mg, 100 mg and 200 mg tablets which can be taken with or without food. The company said moderate alcohol consumption of up to three drinks does not preclude Stendra use. In a double-bling placebo controlled study comprising 440 test subjects Stendra a high proportion of users reported having erection in 15 minutes and sustainable for successful intercourse.

In Europe, the drug is sold as Spedra. Business Insider reported that the announcement of FDA's approval caused shares of Vivus to increase by 12 per cent. The marketing rights of the drug in US and Canada rest with Auxilium Pharmaceuticals.

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