The US Food and Drug Administration (FDA) will review Vivus’ new drug application for avanafil as a treatment for erectile dysfunction.
Avanafil, a highly selective phosphodiesterase type 5 inhibitor, is licensed from Mitsubishi Tanabe Pharma.
Earlier pivotal Phase III trials, which included 1,350 patients, demonstrated that patients treated with avanafil achieved improvement in erectile dysfunction compared to placebo.
Avanafil was also found to be well tolerated and effective in treating patients with general erectile dysfunction and diabetics with erectile dysfunction.
The new drug application process is scheduled for completion before 29 April 2012.