The US Food and Drug Administration (FDA) voted on Friday to approve a new drug to treat erectile dysfunction (ED), various media outlets have reported.
The medication, Stendra (genetic name: avanafil), is produced by California-based pharmaceutical company Vivus Inc. and is the first product from that company to receive FDA approval, according to Jennifer Corbett Dooren of the Wall Street Journal.
Like Viagra, Cialis, and Levitra, Stendra is a phosphodiesterase type 5 (PDE-5) inhibitor which works by increasing blood flow to the penis, Medical News Today said Friday. It is the first PDE-5 inhibitor to be approved by the federal drug agency in a decade, added MedPage Today Staff Writer Charles Bankhead.
“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,” Dr. Victoria Kusiak, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in a press release, according to Daniel J. DeNoon of WebMD Health News.
Bankhead said that the FDA opted to approve Stendra based largely on the results of three randomized, controlled clinical trials involving more than 1,200 ED patients. In one of those trials, scientists observed that men achieved erection in as little as 15 minutes after taking the drugs, and that the rate of erections sufficient for sexual intercourse increased from under 15% to 57% with the new medication (compared to 27% with placebos).
“In clinical trials, 77% of men with general ED were able to get erections after taking Stendra, compared to 54% of men taking an inactive placebo pill. Among men with diabetes-related ED, 63% were able to get erections after taking the drug, compared to 42% of men taking placebo,” said DeNoon. “Stendra resulted in successful intercourse for 57% of men with general ED (vs. 27% of men taking placebo) and for 40% of men with diabetes-related ED (vs. 20% of men taking placebo).”
Dooren said that the FDA has warned that, like other PDE-5 inhibitors, Stendra should not be used by anyone who takes nitrates for chest pain because it could result in a risky decrease in blood pressure. They also reported that the primary side effects from the trials included headaches, redness in the face or in other parts of the body, nasal congestion, or back pain.
She added that Vivus is also “awaiting an FDA decision on its proposed obesity drug Qnexa, which is expected in mid-July“¦ An FDA advisory panel voted 20-2 in support of the product in February in advance of an initial April 17 FDA deadline“¦ Qnexa is a controlled-release formulation that combines low doses of two older generic drugs: the stimulant phentermine, which cuts appetite, and topiramate, which increases the sense of feeling full.”