Vivus Inc. (VVUS) recently reported positive results on its erectile dysfunction (ED) treatment, avanafil, from a late-stage trial (TA-303).
The candidate met all the primary endpoints of the study, which include 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 as early as 15 minutes after taking avanafil.
Detailed results from the study are scheduled to be released in mid June at the Cancer Survivorship and Sexual Health Symposium.
The TA-303 study was conducted to evaluate the safety and efficacy of avanafil in the treatment of ED following bilateral, nerve-sparing, radical prostatectomy in men with ED.
On average, the patients enrolled were 58 years old, 19 months past their 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 sexual activity.
The positive data from TA-303 comes a few days after the company reported positive results on avanafil from another late-stage trial (TA-314). The data were presented at the Annual Meeting of the American Urological Association.
The study data demonstrated that among patients on avanafil, 80% of sexual attempts resulted in erections sufficient for intercourse, as measured both by SEP 2 and SEP 3. It was also observed that erectile function improved over 80% from baseline in patients on avanafil, as measured by IIEF.
This study also showed that successful intercourse was achieved as early as 15 minutes after taking the drug.
The TA-314 study was conducted to evaluate the long-term safety, efficacy and tolerability of avanafil in diabetic and non-diabetic men with ED. On average, patients entering the study had ED for at least six years.
In the study, all patients were initially dosed 100 mg of avanafil 30 minutes prior to initiation of sexual activity. Patients could then increase the dose to 200 mg for improved efficacy or decrease the dose to 50 mg for improved tolerability.
TA-314 is one of the three trials in Vivus’ phase III program for avanafil. The other two are TA-301 (REVIVE) and TA-302 (REVIVE-Diabetes).
Each of these trials has a similar trial design with patients undergoing a four-week, non-treatment run-in period followed by 12 weeks of treatment.
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; secondary endpoints comprise patient satisfaction with erections and sexual experience.
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 EU.
Currently available ED treatments include 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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