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news.Vivus has presented new data from an analysis of the recently completed phase 3 study (Revive TA-301) of Avanafil, an investigational drug candidate for the treatment of erectile dysfunction (ED).
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The company claims that patients who attempted intercourse within 15 minutes of dosing were successful 67%, 69% and 72% of the time on 50, 100 and 200mg of Avanafil, respectively, as compared to 29% of the patients on placebo.
The previously-disclosed top-line results of the Revive study, evaluating the safety and efficacy of Avanafil in 646 patients, showed that all three doses of Avanafil met the FDA-defined primary study endpoints. They demonstrated improvement in erectile function as measured by the sexual encounter profile (SEP) and improvements in the International Index of Erectile Function (IIEF) score.
Leland Wilson, chief executive officer of Vivus, said: “The magnitude of success in the first 15 minutes was surprising. The previously released results demonstrated rapid onset and a long duration of effect. In order to determine how quickly patients had success with Avanafil, an analysis of the results was performed, which showed efficacy in 15 minutes. This new data further strengthens the profile and differentiation of Avanafil from other currently available oral ED therapies. We knew from the pharmacokinetic profile that Avanafil works very quickly; this data is exciting evidence of how fast Avanafil really works.”
The study was a randomized, double-blind, placebo-controlled phase 3 study of Avanafil in 646 men with a history of generalized ED for at least six months; 72% of study participants had tried at least one other ED treatment. Patients underwent a four-week, non-treatment run-in period followed by 12 weeks of treatment with one of three doses of Avanafil: 50mg, 100mg and 200mg, or placebo. Patients were instructed to attempt sexual intercourse 30 minutes after taking Avanafil, with no restrictions on food or alcohol consumption.
The primary endpoints of the study were improvement in erectile function as measured by the sexual encounter profile (SEP) and improvements in the EF Domain of the International Index of Erectile Function (IIEF) score; secondary endpoints included patient satisfaction with erections and with sexual experience. The phase 3 study was conducted under a Special Protocol Assessment with the FDA.
Revive is the first of four phase 3 Avanafil trials. Additional phase 3 studies include treatment in diabetic males with ED (Revive-Diabetes, TA-302) and in males with ED following a radical prostatectomy (TA-303), each with a treatment period of approximately 16 weeks. In March 2009, Vivus initiated an open-label safety study (TA-314) evaluating the long-term safety and tolerability of Avanafil as part of its path toward NDA filing. Results of the study are expected to be available by late 2010.