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news.The US Food and Drug Administration (FDA) has accepted to review US based Vivus' new drug application (NDA) of its experimental drug avanafil as a treatment for erectile dysfunction (ED).
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The results from Phase 3 trials demonstrated improvement in erectile function in comparison to placebo.
The avanafil development program included over 1,350 patients and avanafil was shown to be well tolerated and effective in treating patients with general ED and diabetics with ED.
Vivus has licensed Avanafil from Mitsubishi Tanabe Pharma.
Vivus president Peter Tam said if approved, avanafil could be a valuable treatment alternative for the 18 million men in the US that suffer from ED.