Vivus Inc. (VVUS) recently reported positive results from a late-stage trial, REVIVE-RP (TA-303), on avanafil. The study evaluated the safety and efficacy of avanafil in the treatment of erectile dysfunction (ED) following bilateral, nerve-sparing, radical prostatectomy.
The candidate met all the primary endpoints of the study, which included improvement from baseline in erectile function as measured by the Sexual Encounter Profile (both SEP2 and SEP3) and improvement in the International Index of Erectile Function (IIEF). Additionally, the data showed that successful intercourse was achieved within 15 minutes of taking avanafil.
On average, the patients who enrolled for the study were 58 years old, 19 months past their prostatectomy surgery dates and diagnosed with severe ED. The patients were given 100 mg or 200 mg of avanafil or placebo and were instructed to take one dose of the drug 30 minutes prior to initiation of their sexual activity.
Vivus’ phase III program for avanafil comprises – TA-301 (REVIVE), TA-302 (REVIVE-Diabetes), and TA-303 (REVIVE-RP) and TA-314 (long-term safety study).
While primary endpoints of these studies include improvement in erectile function as measured by the SEP and improvements in the EF-Domain of the IIEF score, as mentioned earlier; secondary endpoints comprise patient satisfaction with erections and sexual experience.
Separately, Vivus has a development, licensing and supply agreement with Mitsubishi Pharma Corporation for avanafil. Mitsubishi Pharma is eligible to receive milestone payments on regulatory filing, approval and sale of the drug in the US and the European Union (EU).
Avanafil on approval will primarily compete with Pfizer Inc.’s (PFE) Viagra and GlaxoSmithKline plc’s (GSK) Levitra.
Our Take
We currently have a Neutral recommendation on Vivus, which carries a Zacks #3 Rank (short-term Hold rating). We are encouraged by the data on avanafil and the company’s plans to file a new drug application (NDA) for the drug with the US Food and Drug Administration in the second quarter of 2011.
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