VIVUS (VVUS) Announces Initiation of Open Label Safety Study for ED
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VIVUS, Inc. (Nasdaq: VVUS) today announced that it has initiated an open label safety study (TA-314) with its investigational drug, avanafil, in males with erectile dysfunction.
VIVUS also announced today that it has completed enrollment in REVIVE (TA-301), a randomized, double-blind, placebo-controlled phase 3 study of avanafil in men with a history of generalized ED and the first of several planned phase 3 studies of avanafil. Approximately 650 patients have been enrolled in the study. Top-line results of REVIVE are expected in the fourth quarter of 2009.
Avanafil, a next-generation, fast-acting, selective, oral, phosphodiesterase type 5 (PDE5) inhibitor, is VIVUS' investigational product for the treatment of ED. The phase 3 program for avanafil is funded through a $30 million collaboration with Deerfield Management.
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