FDA approves Vivus ED drug Stendra

NEW YORK (AP) -- The Food and Drug Administration on Friday approved a new impotence drug, Vivus Inc.'s Stendra.

The pill is intended to be taken 30 minutes before sex, but Vivus said that in clinical trials, some patients were able to have sex as little as 15 minutes after taking the drug. Pfizer Inc.'s Viagra is supposed to be taken at least 30 minutes before sex. The FDA said an estimated 30 million men have importance, or erectile dysfunction.

In clinical trials, the most common side effects of Stendra, or avanafil, were headache, redness of the face and other areas, nasal congestion, back pain, and symptoms similar to the common cold. Vivus said the drug shouldn't be taken more than once per day.

Vivus licensed Stendra from Japanese drugmaker Mitsubishi Tanabe Pharma. It has worldwide rights to the drug except for some countries in the Asia-Pacific region.

Vivus has said it is talking to potential marketing partners for Stendra, and may sell the drug outright to another company. Analysts said Friday they expect Vivus to sell Stendra to another drug company to help fund future sales of its experimental obesity drug Qnexa.

"Given the large market opportunity and the potentially differentiating faster onset of action, we believe that in the hands of big pharma Stendra is probably worth around $300 million," said Cowen and Co. analyst Simos Simeonidis.

Simeonidis said Vivus will need a partner to help sell Qnexa, and will turn to a large pharmaceutical company with experience launching major drugs. He said it's also possible that another company could buy Vivus.

Rodman and Renshaw analyst Michael King said Vivus could get as much as $100 million for the rights to Stendra. He estimated that U.S. sales could peak at $483 million in 2016. After that, he said sales are likely to fall because generic versions of Viagra and other drugs will reach the market.

Vivus is based in Mountain View, Calif. The FDA was scheduled to make a decision on Qnexa this month, but announced it is extending its review by another three months. It is now expected to make a ruling by July 17.

Shares of Vivus ended the session up 72 cents, or 3 percent, at $25.15. After-hours the stock picked up 40 cents to $25.55.