Vivus Inc. (VVUS) recently presented positive data from a late-stage trial on its erectile dysfunction (ED) candidate, avanafil, at the 47th European Association for the Study of Diabetes Annual Meeting. The REVIEW-Diabetes study (TA-302), which enrolled 390 patients with type I and type II diabetes, demonstrated that patients receiving avanafil achieved significant improvement in erectile function.
The data reported that patients dosed with avanafil showed improvement in the percentage of successful intercourse attempts, regardless of diabetes classification (type I or II), duration of diabetes, or baseline ED severity. Further, successful intercourse was achieved in some patients within 15 minutes of taking avanafil. Moreover, some patients experienced successful intercourse more than six hours after dosing.
On average, the patients who enrolled for the study were 58 years old and had a mean duration of diabetes of 11 years and ED of 5 to 6 years. The patients were given 100 mg or 200 mg of avanafil or placebo for 12 weeks.
We note that early this month, the US Food and Drug Administration (FDA) accepted Vivus’s new drug application (NDA) for avanafil, which was submitted in late June 2011 for review. The regulatory body has set a target date of April 29, 2012 for the drug.
The company’s NDA for avanafil is supported by data from three phase III trials – TA-301 (REVIVE), TA-302 (REVIVE-Diabetes) and TA-314 (long-term safety study).
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).
We currently have a Neutral recommendation on Vivus. The stock carries a Zacks #3 Rank (Hold rating) in the short run. We are looking forward to the approval of avanafil for the treatment of ED as it would be Vivus’s first marketed product.
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