MOUNTAIN VIEW, Calif., April 26, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of a marketing authorization for avanafil (SPEDRA™) for the treatment of erectile dysfunction (ED) in the European Union. The CHMP recommendation will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union. A final decision from the EC regarding the SPEDRA Marketing Authorization Application (MAA) is expected within approximately two months. "We are pleased with the positive recommendation of the CHMP to support the approval of SPEDRA," said Peter Tam, president of VIVUS, Inc. "This positive opinion marks another important milestone in the drug development history of VIVUS. We could not have accomplished this without the longstanding collaboration and support of our partner Mitsubishi Tanabe Pharma Corporation and our European team of advisors and consultants, all of whom have worked diligently on the application. If approval of the MAA is granted by the EC, we expect to complete our partnering discussions on a timely basis to allow for the commercialization of SPEDRA in the EU." "SPEDRA is the first next-generation PDE5 inhibitor and offers a unique profile for the treatment of ED," said Prof. Francesco Montorsi, FRCS, Professor and Chairman, Department of Urology and Director, Urological Research Institute, Università Vita Salute San Raffaele, Milan, Italy. "Its onset of action, PDE5 inhibition selectivity and absorption profile make it an important new treatment option for the more than 20 million ED sufferers in Europe. We look forward to the launch of SPEDRA and to providing patients with this important new medication." The MAA incorporated results from three placebo-controlled, randomized, double-blind, multicenter studies: REVIVE, which included 646 men from the general population with ED, REVIVE-Diabetes, which included 390 men with diabetes, and REVIVE-RP, which included 298 men following radical prostatectomy. Also contained within the MAA were the results from the year-long safety study, TA-314, which included 712 continuation patients from the REVIVE and REVIVE-Diabetes studies. Previously reported highlights from the avanafil development program include:
- All doses tested, 50 mg, 100 mg and 200 mg, met each of the co-primary efficacy endpoints;
- Erections sufficient for penetration (SEP2) were observed in 77% and 63% of avanafil patients at the 200 mg dose, compared to 54% and 42% of placebo patients in the REVIVE and REVIVE-Diabetes studies, respectively;
- Successful intercourse (SEP3) was achieved in 57% and 40% of avanafil patients at the 200 mg dose, compared to 27% and 20% of placebo patients in the REVIVE and REVIVE-Diabetes studies, respectively;
- Significant improvement in erectile function as measured by IIEF-EF domain score was observed for all doses in avanafil-treated patients;
- Across all avanafil Phase 3 studies, successful intercourse (SEP3) was observed in some avanafil-treated patients as early as 15 minutes after dosing;
- The most common side effects were headache, flushing, nasopharyngitis and nasal congestion; and
- There were no drug-related serious adverse events reported in the studies.