Vivus Inc. (VVUS) announced Friday that the U.S. Food and Drug Administration has approved Stendra or avanafil tablets for the treatment of erectile dysfunction or ED.
The company said that more than 1,200 men with ED participated in clinical studies evaluating the efficacy and safety of Stendra. Stendra at all doses tested (50mg, 100mg and 200mg) met all primary efficacy endpoints. Significant improvement in erectile function was observed for all doses in Stendra -treated patients compared to placebo.
It is recommended that Stendra should be taken approximately 30 minutes before sexual activity. Stendra should not be taken more than once per day, the company said.
Vivus noted that it is currently in discussion with potential partners to commercialize Stendra in the United States and in its territories in the rest of the world.
Stendra (avanafil) is licensed from Mitsubishi Tanabe Pharma Corporation. Vivus said it has development and commercial rights to Stendra for the treatment of sexual dysfunction worldwide with the exception of certain Asian Pacific Rim countries. In South Korea, Stendra is approved and is marketed by JW Pharma under the brand name Zepeed.
The company advised that do not take Stendra if you take nitrates, often prescribed for chest pain, as this may cause a sudden, unsafe drop in blood pressure. Stendra in combination with other treatments for ED is not recommended.
The company stated that the most common side effects of Stendra are headache, flushing, runny nose and congestion.
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