The ED Drug to be sold under brand name Stendra belongs to same class as Viagra, Cialis and Levitra

U.S. health regulators on
Friday approved Vivus Inc.'s avanafil treatment for
erectile dysfunction, giving the small company, which has 
struggled to bring a weight loss drug to market, a potentially 
lucrative commercial product.

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

Stendra, which belongs to the same class of medicines called
PDE5 inhibitors as Viagra, Eli Lilly's Cialis and
Levitra, sold by Glaxo-Smith-Kline and Bayer,
works by increasing blood flow to the penis.

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 milligrams, 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.

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

The most common side effects reported in greater than 2
 percent of patients in the clinical studies 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.

Vivus shares were up 4.5 percent at $25.53 on Nasdaq before
being halted prior to the FDA announcement.

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