The FDA has approved avanafil (Stendra) for the treatment of erectile dysfunction (ED), making it the first drug to be approved for the condition in nearly 10 years.
Manufactured by Vivus of Mountain View, Calif., avanafil met all primary efficacy endpoints in more than 1,200 men with ED who participated in clinical studies, according to a press release issued by the company. Significant improvements in erectile function were observed for all doses (50 mg, 100 mg, and 200 mg) compared with placebo.
“Patients and treating physicians continue to report significant dissatisfaction with current treatments of ED,” said Peter Tam, president of Vivus.
It is recommended that avanafil be taken about 30 minutes before sexual activity. It should not be taken more than once per day.