Vivus announced that the FDA has accepted its New Drug Application (NDA) for avanafil for the treatment of erectile dysfunction (ED). The target date to complete the review is April 29, 2012. In previously announced results from the pivotal Phase 3 trials, patients treated with avanafil achieved significant improvement in erectile function compared 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. The long-term safety study also confirmed the results observed in the Phase 3 studies.
Avanafil is a highly selective phosphodiesterase type 5 (PDE5) inhibitor.
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