Vivus is right on time with its NDA for avanafil, a drug for erectile dysfunction licensed from Japan's Mitsubishi Tanabe Pharma. The drug was tested in 1,350 men, some of whom had diabetes. Data from three late-stage trials demonstrated that avanafil was effective and well-tolerated. If approved, avanafil will compete with other well-established ED blockbusters from Pfizer, Eli Lilly and GlaxoSmithKline.
"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," said Vivus CEO Leland Wilson. "The unique profile of potentially faster onset and greater selectivity should allow avanafil to effectively compete in the $4 billion worldwide ED market."
The filing is much-needed good new for Vivus, which has been stymied by the FDA in its attempts to gain approval for obesity drug Qnexa.