MOUNTAIN VIEW, Calif., June 17, 2011 /PRNewswire/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced that the positive results from REVIVE-RP (TA-303), a phase 3 clinical trial evaluating the safety and efficacy of the investigational drug avanafil for the treatment of erectile dysfunction (ED),will be presented this afternoon at the 2011 Cancer Survivorship and Sexual Health Symposium in Washington D.C. The meeting is jointly sponsored by the International Society for Sexual Medicine (ISSM) and the Sexual Medicine Society of North America (SMSNA). John Mulhall, M.D., Director of the Male Sexual & Reproductive Medicine Program at the Memorial Sloan Kettering Cancer Center in New York, will present the results during the peer-reviewed, moderated poster session.
Avanafil met all primary endpoints by demonstrating improvements from baseline in erectile function as measured by the Sexual Encounter Profile (both SEP 2 and SEP 3) and improvement in the erectile function domain of International Index of Erectile Function (IIEF). The study also indicated a favorable safety profile and successful intercourse (as measured by SEP 3) was observed as early as 15 minutes after dosing, without any restrictions on food or alcohol.
"Patients who have undergone a radical prostatectomy (RP) often have severe erectile dysfunction. Despite advancements in surgery, it can take several months or years to normalize erections. RP patients are difficult to treat but the positive results of avanafil in these patients suggest that, if approved, avanafil could be an attractive treatment option for these patients," commented Dr. Mulhall. "I am pleased to be presenting these positive results with the health professionals attending the Cancer Survivorship Meeting. The safety and efficacy demonstrated in this trial may offer hope to patients who have been unable to return to normal erectile function following their surgery."
Highlights of the TA-303 study include:
About the StudyTA-303 was a randomized, double-blind, placebo-controlled, parallel group, multicenter study of the safety and efficacy of avanafil in the treatment of erectile dysfunction following bilateral, nerve-sparing, radical prostatectomy in 298 men with ED. On average, subjects entering the study were 58 years old, 19 months past their surgery dates with documented severe ED. Subjects were randomized to 100 mg or 200 mg avanafil or placebo and were instructed to take one dose of study drug 30 minutes prior to initiation of sexual activity. The study had a four-week run-in period followed by 12 weeks of treatment. The primary endpoints of the study were improvements in erectile function as measured by the SEP2 and SEP3 and improvement 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 studies: TA-301 (REVIVE), TA-302 (REVIVE-Diabetes), and TA-303 (REVIVE-RP) and a 52-week, open-label, long-term safety study (TA-314). TA-301, TA-302 and TA-303 were all randomized, double-blind, placebo-controlled phase 3 studies of avanafil in 646, 390, and 298 men respectively with a history of ED for at least six months. Each of the pivotal trials had 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 were 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 all three studies, all doses of avanafil tested met the primary endpoints, with successful intercourse achieved by some subjects in 15 minutes or less after administration.
TA-314 evaluated avanafil for up to 52-weeks in 712 men, 486 with a history of ED and 226 diabetic men with ED across 40 centers throughout the U.S. Patients completing REVIVE (TA-301) or REVIVE-Diabetes (TA-302) were eligible for rollover into TA-314. 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 a favorable side effect profile and successful intercourse (as measured by SEP 3) in as little as 15 minutes and beyond six hours after dosing, without any restrictions on food or alcohol intake.
VIVUS 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 AvanafilAvanafil is an investigational oral medication being developed for the treatment of erectile dysfunction. Avanafil is a highly selective phosphodiesterase type 5 (PDE5) inhibitor licensed from Mitsubishi Tanabe Pharma Corporation. With the exception of certain Asian Pacific Rim countries, VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual 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 U.S. 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 has completed 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," "estimate," "expect," "forecast" 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 QNEXA CRL; 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 QNEXA 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 CRL on QNEXA 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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