REVIVE Trial Results for Avanafil Published in JSM Demonstrate Significant Improvement in Erectile Function
MOUNTAIN VIEW, Calif., Jan. 17, 2012 /PRNewswire/ — VIVUS, Inc. (NASDAQ: VVUS) today announced that results from the REVIVE study were published in The Journal of Sexual Medicine (JSM), a peer-reviewed journal with broad, multidisciplinary readership. REVIVE (TA-301) was a randomized, placebo-controlled, phase 3 study evaluating the safety and efficacy of avanafil, an investigational drug currently under review by the Food and Drug Administration (FDA) for the treatment of erectile dysfunction (ED). In addition to significant improvements in erectile function and low rates of side effects common to phosphodiesterase type 5 inhibitors, the study also found that patients who attempted intercourse within 15 minutes of dosing were successful 64%, 67% and 71% of the time with 50, 100 and 200mg of avanafil treatment, respectively, versus 27% for placebo (p < 0.0001). The data suggest that avanafil may provide a rapid-onset, well-tolerated and effective treatment option for erectile dysfunction.
“While PDE-5 inhibitors are currently used as first-line therapy for treatment of ED in the general population, what’s new and novel about avanafil is that it has a fast onset of action and high selectivity,” said lead Investigator Irwin Goldstein, MD, Director of San Diego Sexual Medicine at Alvarado Hospital. “For patients, this means that avanafil, if approved, could be taken on-demand with potentially fewer side effects.”
An overview of the results as published in JSM is as follows:
- Following 12 weeks of treatment, without restrictions on food or alcohol, all three doses of avanafil (50mg, 100mg and 200mg) were significantly superior to placebo for all primary endpoints (p </= 0.001).
- A secondary analysis using Sexual Encounter Profile, question 3 (SEP 3) to evaluate the number of successful intercourse attempts at various time points post-dosing revealed that avanafil was associated with a significant treatment response as early as 15 minutes and beyond 6 hours after dosing.
- Nearly 80% of all sexual attempts among patients in the 200mg dose group of avanafil had erections sufficient for intercourse.
- 72% of study participants had tried at least one other ED treatment.
- The most common side effects were headache, flushing, nasal congestion and back pain and no drug-related serious adverse events reported.
- The completion rate in REVIVE was 85.1% and discontinuations due to adverse events were 1.9%, 3.1%, 2.5% and 3.1% for the 50mg, 100mg, 200mg and placebo groups, respectively.
About the REVIVE Study
REVIVE (TA-301) was a randomized, double-blind, placebo-controlled, phase 3 study of avanafil in 646 men in the general population with a history of 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, 100 mg 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 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 U.S. FDA.
Avanafil is an oral investigational drug being developed for the treatment of erectile dysfunction. Avanafil is a highly selective phosphodiesterase type 5 (PDE5) inhibitor licensed from Mitsubishi Tanabe Pharma Corporation. VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian Pacific Rim countries.
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. We resubmitted the Qnexa NDA in October 2011, with an FDA action date of April 17, 2012. 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 submitted an NDA for avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction, with an FDA action date of April 29, 2012. 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,” “expect,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “opportunity” and “should,” 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 response from the United States Food and Drug Administration, or FDA, to our resubmission of the New Drug Application, or NDA, for Qnexa for the treatment of obesity, including weight loss and maintenance of weight loss, recommended for obese patients (BMI >/= 30 kg/m2), or overweight patients (BMI >/= 27 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity), with a contraindication that excludes the use of Qnexa by women who are pregnant; the timing and results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy, or the FORTRESS study; the reliability of the electronic medical claims healthcare databases used in the FORTRESS study; the FDA’s interpretation of and agreement with the information VIVUS submitted relating to teratogenicity and cardiovascular safety; the FDA’s interpretation of the data from our SEQUEL study (OB-305) and Sleep Apnea study (OB-204); that we may be required to provide further analysis of clinical trial data; our response to questions and requests for additional information including additional pre-clinical or clinical studies from the European Medicines Agency, or EMA, and the Committee for Medicinal Products for Human Use, or CHMP, of the Marketing Authorization Application, or MAA, for Qnexa; the results of external studies to assess the teratogenic risk of topiramate; results of the REMS or cardiovascular outcomes for obesity advisory meetings; the outcome of the second advisory committee meeting for Qnexa; the impact, if any, of the agreement by one of our competitors with an obesity compound to conduct or complete a cardiovascular outcomes study pre-approval; impact on future sales based on specific indication and contraindications contained in the label and extent of the REMS, distribution and patient access program; the FDA’s response to the NDA filed for avanafil; our ability to successfully commercialize or establish a marketing partnership for avanafil or our partner’s ability to obtain regulatory approval to manufacture and adequately supply avanafil for commercial use; our history of losses and variable quarterly results; substantial competition; risks related to the failure to protect our intellectual property and litigation in which we may become involved; uncertainties of government or third party payer reimbursement; our reliance on sole source suppliers; our limited sales and marketing efforts and our reliance on third parties; failure to continue to develop innovative investigational drug candidates and drugs; risks related to the failure to obtain FDA or foreign authority clearances or approvals and noncompliance with FDA regulations; our ability to demonstrate through clinical testing the safety and effectiveness of our investigational drug candidates; our dependence on the performance of our collaborative partners; the timing of initiation and completion of clinical trials and submissions to the FDA or foreign authorities; the volatility and liquidity of the financial markets; our liquidity and capital resources; and our expected future revenues, operations and expenditures. 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 or CHMP’s 120-day questions, the FDA’s requests stemming from the end-of-review meeting or the results of the FORTRESS study and subsequent meetings and communications will be sufficient to satisfy the FDA or CHMP’s safety concerns, that the FDA or foreign authorities 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.
Timothy E. Morris
Chief Financial Officer
Investor Relations: The Trout Group