Newest Erectile Dysfunction Drug Approved By FDA

It has been a decade since any new treatments have been added to the pharmaceutical offerings for treatment of erectile dysfunction, or ED. On April 27, 2012, the U.S. Food and Drug Administration issued a press release announcing that the agency had approved a new medication, Stendra, that is intended to aid in the treatment of ED.

The Role of Clinical Research Studies

As with any new drug seeking approval from the FDA, years of background testing first in laboratories and then in humans must be completed. The research conclusions must demonstrate both effectiveness of the drug and its safety.

A total of three double-blind, placebo-controlled clinical studies that included more than 1200 participants. Study participants were followed for a 12-week course of one of the three dosages available for avanafil or a placebo 30 minutes prior to sexual activity; a smaller subset was monitored for an additional forty weeks.

The FDA reports that study participants, who were asked every four weeks to complete a questionnaire on erectile function, vaginal penetration and sexual intercourse, showed a “statistically significant improvement” in all three areas with each of the available doses.

Side effects of Stendra reported in more than 2 percent of study participants included headache, facial flushing, back pain and nasal congestion. As with the other PDE5 inhibitors, there is the possibility of the rare occurance of an erection that lasts longer than four hours (priapism) that requires immediate medical attention.

Bottom Line

Precautions with Stendra are the same as with the other ED medications: men who take nitrate medications should not take this medication and severe side effects such as vision and hearing changes/loss may occur.

As the physician in the accompanying video explains, only you and your doctor can determine if this new medication is right for you.

This article is informational only. It is not intended to take the place of or replace information from your health care provider. Always consult your health care provider for questions/concerns about your health.

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