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FDA approves Stendra for erectile dysfunction

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There is a new and FDA-approved erectile dysfunction drug on the market for the estimated 30 million men in the United States affected by this condition. It's called Stendra.

Grand Rapids' men, as well as men across the country, will have yet another option for treating their erectile dysfunction. Erectile dysfunction, ED, is when a man has trouble getting or keeping an erection.

Stendra is a pill that patients take on an as-needed basis 30 minutes before sexual activity. Stendra belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, which are used to help increase blood flow to the penis. The drug should not be used by men who also take nitrates, commonly used to treat chest pain (angina), because the combination can cause a sudden drop in blood pressure.

A total of 1,267 patient were randomly assigned to take Stendra for up to 12 weeks, or a placebo as needed about 30 minutes before sexual activity. At the start of the studies, and every four weeks thereafter, patients completed questionnaires to evaluate erectile function, vaginal penetration and successful intercourse. Results showed patients taking Stendra experienced statistically significant improvement in all three endpoints.

The most common side effects reported in greater than 2 percent of patients in the clinical studies of Stendra include headache, redness of the face and other areas, nasal congestion, common cold-like symptoms, and back pain.

Stendra is marketed by Mountain View, California-based VIVUS Inc.

FDA drug announcement

VIVUS press release

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