ED sufferers may not have to plan for sex anymore, thanks to Stendra

Avanafil, which will be sold under the brand name Stendra, is the first new erectile dysfunction drug in the category in a decade.

Stendra -- which will compete with Viagra, Cialis and Levitra gives Vivus, which has struggled to bring a weight loss drug to market, a potentially lucrative commercial product.

Stendra will have some attractive marketing claims as it goes up against established erectile dysfunction medicine rivals sold by companies with serious marketing muscle.

"Stendra is potentially the fastest acting erectile dysfunction drug of the four," said Dr Wayne Hellstrom, professor of urology at Tulane University School of Medicine in New Orleans.

While it is recommended that patients take the new Stendra (Avanafil) pill 30 minutes prior to sexual activity, in clinical trials Stendra has been shown to work in as fast as 15 minutes. Viagra, Cialis & Levitra typically take about an hour to start working.

Stendra belongs to the same PDE5 inhibitor class of erectile dysfunction medications as its rivals and also works by increasing blood flow to the penis. But researchers found Stendra to be more selective than the older erectile dysfunction drugs, meaning Stendra could have fewer unintended effects.

"Higher selectivity should translate into fewer erectile dysfunction medicine side effects," said Hellstrom. "Stendra is going to add more excitement" to the field of erectile dysfunction drugs.

ED (erectile dysfunction) afflicts as many as 30 million men in the U.S., Vivus said. The Vivus drug, Stendra (Avanafil), is currently awaiting a European Medicines Agency approval decision.

Cowen and Co analyst Simos Simeonidis, in a research note, forecast annual Stendra sales of about $300 million. Viagra had sales of about $2 billion in 2011.

Vivus shares were up about 3 percent following the expected approval of Stendra by the Food and Drug Administration. Investors are far more focused on the prospects for Vivus's obesity pill Qnexa, for which the FDA is expected to rule by mid July.

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

"This Stendra approval expands the available erectile dysfunction treatment options to men experiencing erectile dysfunction, and enables patients, in consultation with their doctor, to choose the most appropriate erectile dysfunction 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.

The most common side effects reported in clinical studies of Stendra (Avanafil) included headache, flushing of the face and other areas, nasal congestion, common cold-like symptoms and back pain.

Stendra (Avanafil) carries the same cautions as its erectile dysfunction drug rivals (Viagra, Cialis & Levitra), including that Stendra (Avanafil) should not be used by men who also take nitrates, due to the potential for a sudden dangerous drop in blood pressure and the now famous warning to see a doctor if an erection lasts more than four hours.

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