FDA Approves Rx for Erectile Dysfunction

Stendra approved for new label indicating it acts in half the time

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Some medications for erectile dysfunction (ED) like Viagra can take up to an hour to begin working before sex. But the Us Food and Drug Administration (FDA) approved a new medicine Thursday that can act in 15 minutes.

Stendra (avanafil) was first approved in 2012 to help men get an erection in 30 minutes. Thursday, the FDA approved a new label for the medicine that says it can work in half that time.

"Ask your pharmacist about new treatments for ED."

"ED patients in my practice are looking for a safe and effective treatment option that also works fast," said Wayne Hellstrom, MD, FACS, lead researcher in a clinical trial for Stendra and a professor of urology at Tulane University School of Medicine in New Orleans, in a press release. "In my opinion, Stendra can be an appropriate and important treatment option because the clinical trial demonstrated that it provides a rapid onset of action in many men in as early as approximately 15 minutes."

Stendra is one medicine in a group called phosphodiesterase type 5 inhibitors. These medicines increase blood flow to the penis. This can help patients with ED — which is marked by an inability to get or maintain an erection — have sexual intercourse.

Stendra comes in 50, 100 and 200 milligram doses. According to a press release, patients can take it with or without food — and even after up to three alcoholic drinks.

Common side effects of Stendra include congestion, runny nose, headache and flushing. In rare cases, users have had sudden impaired vision or hearing when taking Stendra.

The FDA approved Stendra for use in men older than 18.

Auxilium Pharmaceuticals markets Stendra in North America.

Review Date: 
September 18, 2014
Last Updated:
September 18, 2014