US FDA clears new ED drug Stendra

The US Food and Drug Administration late Friday gave its approval for drug developer Vivus (Nasdaq: VVUS) to market its Stendra (avanafil) tablets for the treatment of erectile dysfunction (ED, marking the first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the USA.

Vivus shares, which closed up 2.9% at $25.15 in anticipation of the favorable FDA decision, rose to $25.40 in after hours trading. Cowen & Co analyst Simos Simeonidis, in a research note quoted by Reuters, forecast annual Stendra sales of about $300 million.

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