MOUNTAIN VIEW, Calif., May 17, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that positive results from a pivotal phase 3 open-label clinical trial evaluating long-term safety and efficacy of the investigational drug avanafil for the treatment of erectile dysfunction (ED) were presented at the 2011 Annual Meeting of the American Urological Association in Washington, D.C. Laurence Belkoff, DO, FACOS, Chairman of the Department of Specialty Surgeries and the Division of Urology at the Philadelphia College of Osteopathic Medicine presented the results during the late-breaking science forum. The top-line results had been previously reported; however, the presentation by Dr. Belkoff marks the first time these results have been presented at a major medical meeting.
The study met all primary endpoints by demonstrating sustained improvement from baseline in erectile function as measured by the Sexual Encounter Profile (both SEP 2 and SEP 3) and improvements in the International Index of Erectile Function (IIEF). The study also indicated that successful intercourse (as measured by SEP 3) was achieved as early as 15 minutes, consistent with results from previously reported phase 3 double-blind, placebo-controlled studies.
"The avanafil data from the open label, long-term safety study confirm the safety and efficacy results previously observed in the two placebo-controlled trials," commented Dr. Belkoff. "The safety profile demonstrated during the year-long study and successful intercourse attempts within 15 minutes of dosing suggest avanafil, if approved, may be an attractive treatment option for men with ED."
Highlights of the TA-314 study include:
About the StudyTA-314 was an open-label extension study evaluating the long-term safety, efficacy and tolerability of avanafil in 712 diabetic and non-diabetic men with ED across 40 U.S. centers. Subjects were eligible to enter into TA-314 upon completion of either TA-301 (REVIVE) or TA-302 (REVIVE-Diabetes) and participation lasted for up to 52 weeks. On average, subjects entering the study had ED for at least six years, with approximately 29% of cases being characterized as mild in severity, 33% moderate and 38% severe. All subjects were started on a 100mg dose of avanafil and were instructed to take one dose of study drug 30 minutes prior to initiation of sexual activity. Subjects were then able to request an increase in dose to 200mg for improved efficacy or a decrease in dose to 50mg for improved tolerability. 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 IIEF score; secondary endpoints included patient satisfaction with erections and with sexual experience.
About the Avanafil Phase 3 ProgramThe avanafil phase 3 program consists of three pivotal studies: TA-301 (REVIVE), TA-302 (REVIVE-Diabetes), and TA-314. TA-301 and TA-302 were randomized, double-blind, placebo-controlled phase 3 studies of avanafil in 646 and 390 men, respectively, with a history of ED for at least six months. A majority of patients in the study had previously used other oral ED therapies. 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. Primary endpoints of the studies are improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the EF domain score of the International Index of Erectile Function (IIEF). In both the TA-301 and TA-302 studies, all doses of avanafil met the primary endpoints, with successful intercourse achieved by some subjects in 15 minutes or less after administration. TA-314 was an open label, long-term safety and efficacy study required as part of the NDA. In TA-314, patients also had significant improvement in erectile function as measured by SEP2, SEP3 and IIEF.
VIVUS has also held a pre-NDA meeting with the FDA to confirm that the pre-clinical and clinical requirements necessary for the filing of an NDA have been met. In total, the phase 3 avanafil clinical program enrolled approximately 1,350 subjects. VIVUS expects to file the NDA for avanafil in the second quarter of 2011.
About Erectile Dysfunction (ED)Erectile Dysfunction (ED) is defined as the inability to attain and maintain an erection sufficient for sexual intercourse. According to the Massachusetts Male Aging Study (MMAS), ED affects an estimated 52 percent of men between the ages of 40 and 70. The prevalence of ED increases with age and can be affected by a variety of factors, including certain medications such as anti-hypertensives and histamine receptor antagonists; lifestyle, such as tobacco or alcohol use; diseases, including diabetes and cardiovascular conditions; and spinal cord injuries. Studies have shown that up to 58% of men with diabetes have erectile dysfunction.
About VIVUS VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigational product in clinical development, QNEXA, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial QNEXA NDA on October 28, 2010. QNEXA is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction. For more information about the company, please visit www.vivus.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate" and "intend," among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the timing and substance of our response to the FDA's requests from the QNEXA End of Review meeting; our response to, and continued dialogue with, the FDA relating to matters raised in the FDA's CRL for QNEXA; the timing and results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy; the FDA's interpretation of and agreement with the information VIVUS submitted and may submit relating to teratogenicity and cardiovascular safety; the FDA's interpretation of the data from our SEQUEL study, or OB-305; the FDA's requests, if any, to conduct additional prospective studies or retrospective observational studies or to provide further analysis of clinical trial data; the review and questions from the EMA and CHMP on the MAA; substantial competition; the impact on future sales based on specific indication and contraindications contained in the label and the extent of the Risk Evaluation and Mitigation Strategies program; uncertainties of litigation and intellectual property and patent protection; reliance on sole-source suppliers; limited sales and marketing resources and dependence upon third parties; risks related to the development of innovative products; risks related to the failure to obtain FDA or foreign authority clearances or approval; noncompliance with FDA or foreign regulations; and our dependence on the performance of our collaborative partners. As with any pharmaceutical in development, there are significant risks in the development, the regulatory approval, and commercialization of new products. There are no guarantees that our response to the FDA's QNEXA CRL or the results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy and subsequent meetings and communications will be sufficient to satisfy the FDA's safety concerns, that the FDA will not require us to conduct any additional prospective studies or retrospective observational studies, or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ending December 31, 2010, and periodic reports filed with the Securities and Exchange Commission.CONTACT:VIVUS, Inc.Investor Relations:The Trout GroupTimothy E. MorrisBrian Korb Chief Financial Officer646-378-2923650-934-5200
|SOURCE VIVUS, Inc.|
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