Reports from Phase 3 study Indicate Significant Market Opportunity for Avanafil (Nasdaq:VVUS)
Windsor, Alberta 11/18/2009 07:10 PM GMT (TransWorldNews)
VIVUS Announces Positive Results From Phase 3 Study of Avanafil in Erectile Dysfunction; Data Demonstrate Robust Efficacy, Favorable Side-Effect Profile
VIVUS, Inc. (Nasdaq:VVUS) recently reported positive results from REVIVE (TA-301), a phase 3 pivotal study evaluating the safety and efficacy of avanafil, an investigational drug candidate for the treatment of erectile dysfunction (ED), in 646 patients. The REVIVE study met all primary endpoints across the three doses studied by demonstrating statistically significant improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the International Index of Erectile Function (IIEF) score. The pivotal study, conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA), also demonstrated successful intercourse in 30 minutes or less, and a favorable side-effect and safety profile.
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"Erectile dysfunction is a significant problem among more than half of all men over the age of 40. While sales of currently available ED therapies exceed $3.8 billion a year, persistent switching by patients suggests that patients are less than satisfied with current therapies," stated Leland Wilson, chief executive officer of VIVUS. "These phase 3 avanafil data not only confirm the robust efficacy we've seen in earlier trials, but potentially differentiate avanafil from other PDE5 inhibitors when it comes to side effects and time-to-onset of efficacy. We are confident that avanafil can effectively compete in the oral ED therapy market." VIVUS is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health. The company's lead product in clinical development, Qnexa(TM), has recently completed phase 3 clinical trials for the treatment of obesity. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a potentially best-in-class PDE5 inhibitor, and in phase 2 development of Luramist(TM) for the treatment of hypoactive sexual desire disorder (HSDD) in women. MUSE® (alprostadil), a first generation therapy for the treatment of ED, is already on the market and generating revenue for VIVUS.
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