Vivus, a US biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health, has initiated an open-label safety study (TA-314) with its investigational drug avanafil, in males with erectile dysfunction.
The firm also said that it has completed enrollment in REVIVE (TA-301), a randomized, double-blind, placebo-controlled Phase III study of avanafil in men with a history of generalized ED and the first of several planned Phase III studies of avanafil. Around 650 patients have been enrolled in the study, top-line results of which are expected in the fourth quarter.
Avanafil is a next-generation, fast-acting, selective, oral, phosphodiesterase type 5 inhibitor. The Phase III program for the drug is funded through a $30.0-million collaboration with Deerfield Management.
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