Vivus Inc. (VVUS) recently provided an update on the regulatory status of its erectile dysfunction (ED) treatment, avanafil. The company said that the US Food and Drug Administration (FDA) accepted its new drug application (NDA) of avanafil submitted in late June 2011, for review. The regulatory body has set a target date of April 29, 2012 for the drug.
Vivus’ 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).
All three aforementioned trials, which tested 50 mg, 100 mg, and 200 mg dosage strengths of avanafil, met the co-primary efficacy endpoints.
The trial results of REVIVE and REVIVE-Diabetes studies demonstrated that at 200 mg dose, erections sufficient for penetration [Sexual Encounter Profile (SEP2)] were observed in 77% and 63% of avanafil patients, as compared to 54% and 42% in patients dosed placebo, respectively.
Additionally, successful intercourse (SEP3) was achieved in 57% and 40% of avanafil patients, compared with 27% and 20% of placebo patients, respectively.
Also, a significant improvement from baseline in erectile function, as measured by the International Index of Erectile Function (IIEF) domain score, was observed for all doses of avanafil-treated patients. Further, in all phase III studies, successful intercourse (SEP3) was achieved in some patients within 15 minutes of being dosed with avanafil.
We note that 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).
Once approved, avanafil 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. 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 the first marketed product at Vivus.
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