Last Friday, the U.S. Food and Drug Administration (FDA) approved Stendra, the first new drug in a decade to treat erectile dysfunction.
Stendra, the brand name for avanafil, is sold by Vivus Inc. and will compete with other erectile-dysfunction drugs currently on the market: Pfizer’s Viagra, Eli Lilly’s Cialis and GlaxoSmithKline and Bayer’s Levitra. Like its competitors, Stendra is among a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, which work by increasing blood flow to the penis.
Based on clinical trials, Stendra may kick in faster than its counterparts — possibly in as little as 15 minutes. “This is potentially the fastest acting of the four,” Dr. Wayne Hellstrom, a professor of urology at Tulane University School of Medicine, in New Orleans, told Reuters.
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In clinical trials, 77% of men with general erectile dysfunction were able to get erections after taking Stendra, compared with 54% of men taking a placebo. Intercourse was successful for 57% of the men on Stendra, compared with 27% of men on the placebo, WebMD reports.
“This approval expands the available treatment options to men experiencing erectile dysfunction, and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs,” Dr. Victoria Kusiak, the deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in an agency statement.
An estimated 30 million American men are affected by erectile dysfunction.
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The new pill should be taken on an as-needed basis 30 minutes before sexual activity. The potential side effects of Stendra include headache, flushing of the face and other areas, nasal congestion, common cold-like symptoms and back pain. Like other PDE5 inhibitors, Stendra should not be used by men who take nitrates to treat chest pains, since the combination can lead to sudden, dangerous drops in blood pressure.
Stendra has been approved at doses of 50 mg, 100 mg and 200 mg. The FDA recommends doctors prescribe the lowest dose needed.