Vivus, Inc. Opens Sharply Higher On ED Drug Marketing Approval

Vivus Inc. VVUS shares rose sharply in pre-market activity after its fast-acting erectile dysfunction drug won marketing approval Thursday from federal regulators.

The drug, avanafil, can be effective when taken as early as 15 minutes before sexual activity, the company said. The U.S. Food and Drug Administration cleared the drug for marketing in its first approval of an erectile dysfunction treatment in nearly 10 years.

"Patients are looking for a safe and effective treatment that also works fast," lead investigator Wayne J.G. Hellstrom of Tulane School of Medicine said.

Vivus holds worldwide development and commercial rights to avanafil, excluding Asia, through a license from Mitsubishi Tanabe Pharma Corp.

Avanafil is to be marketed as Stendra by Auxilium Pharmaceuticals Inc. under a Vivus license covering the U.S. and Canada.

Berlin-Chemie AG holds a similar license from Vivus covering much of Europe, Australia and New Zealand, while Sanofi SA sells the drug in the Middle East and Russia.

After opening sharply higher, Vivus traded recently at $4.25 per share, up a 9.5 percent.