Vivus’s NDA accepted by FDA for Avanafil (and ED drug)

Vivus Inc. has declared that the U.S. Food and Drug Administration have accepted for review the company's new drug application or NDA. FDA would be reviewing Vivus Inc.’s investigational drug candidate called avanafil for treating the problem of erectile dysfunction in males. The company has also announced April 29, 2012 as the target date for the FDA to complete its review of the product’s NDA.

There has been a previously announced report of the phase 3 trials with the product avanafil that talks of results that it yielded. The report said that patients who were treated with avanafil saw noteworthy improvement in the erectile function as compared to placebo. A program called the avanafil development program was conducted that included over 1,350 patients and avanafil was displayed as one of the most tolerated and effective drug in treating patients with General ED and diabetics patients with ED. The company also said in its report that results observed in the phase 3 also confirmed by the long-term safety study.

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