US NDA filings for Vivus' ED drug avanafil and Corcept's Corlux for Cushing's

California, USA-based Vivus (Nasdaq: VVUS) has submitted a New Drug Application has to the Food and Drug Administration seeking approval of avanafil, its investigational drug for the treatment of erectile dysfunction (ED). The NDA submission follows the successful completion of an extensive Phase III program for avanafil, which included over 1,350 patients, where avanafil was shown to be well tolerated and effective in treating men with ED, the company noted.

"This NDA filing is yet another major milestone for Vivus and the avanafil program. The efficacy was consistent across all patient groups, with success observed in some patients in as early as 15 minutes after dosing. The drug was well tolerated and had a low dropout rate in all of the clinical trials. If approved, avanafil could be an attractive treatment alternative for the 30 million men in the United States who suffer from ED," stated Leland Wilson, chief executive of Vivus, adding: "The unique profile of potentially faster onset and greater selectivity should allow avanafil to effectively compete in the $4 billion worldwide ED market.”

FDA accepts Corlux submission