Vivus Inc. (VVUS) announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational drug, avanafil. The company is seeking to get the drug approved for the treatment of erectile dysfunction (ED).
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, which carries a Zacks #3 Rank (short-term Hold rating). We are encouraged by the company’s NDA filing for avanafil as the drug was Vivus’ lead pipeline candidate along with Qnexa, which is being evaluated as a potential treatment for obesity, type II diabetes and obstructive sleep apnea.
While Qnexa is in mid-stage trials for type II diabetes and obstructive sleep apnea, Vivus received a Complete Response Letter (CRL) in October 2010 from the FDA for Qnexa for the weight loss indication. The company plans to resubmit the NDA for Qnexa as a treatment for obesity by the end of 2011.
Vivus is also trying to get Qnexa approved in the EU as a treatment for obesity. A decision from the European Medicines Agency (EMA) is expected in late 2011.
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