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FDA approves Vivus drug for erectile dysfunction

WASHINGTON (Reuters) – U.S. health regulators on Friday approved Vivus Inc.’s avanafil treatment for erectile dysfunction.

The U.S. Food and Drug Administration said the pill, which will compete with Pfizer’s Inc’s Viagra and other erectile dysfunction drugs, will be sold under the brand name Stendra.

The Vivus drug will have some attractive marketing claims. “This is potentially the fastest acting” of the available drugs, said Dr Wayne Hellstrom, professor of urology at Tulane University School of Medicine in New Orleans.

Patients are instructed to take Stendra 30 minutes before sexual activity but in clinical trials it has been shown to work in as little as 15 minutes.

The drug is awaiting a European approval decision.

Doctors should prescribe the lowest dose of Stendra that provides benefit, the FDA said. It has been approved at doses of 50 mg, 100 mg and 200 mg.

“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,” Victoria Kusiak, deputy director of the Office of Drug Evaluation in the FDA’s Center for Drug Evaluation and Research, said in a statement.

Like Viagra, Eli Lilly’s Cialis and Levitra, sold by GlaxoSmithKline and Bayer, Stendra is a phosphodiesterase 5 inhibitor that works by increasing blood flow to the penis. But researchers say it is more selective than the older drugs.

“Higher selectivity should translate into fewer side effects,” said Dr. Hellstrom. “It’s going to add more excitement” to the field.

The most common side effects reported in greater than 2% of patients included headache, flushing of the face and other areas, nasal congestion, common cold-like symptoms and back pain.

The drug carries the same cautions as its rivals, including that it should not be used by men who also take nitrates due to the potential for a sudden dangerous drop in blood pressure and the warning to see a doctor if an erection lasts more than four hours.