MOUNTAIN VIEW, Calif., June 1 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced that data from the previously reported phase 3 pivotal REVIVE (TA-301) study, evaluating the safety and efficacy of the investigational drug avanafil for the treatment of erectile dysfunction (ED), were presented at the American Urological Association (AUA) 2010 Annual Meeting. The data, "Avanafil for the Treatment of Erectile Dysfunction: Results of a Phase 3, Multi-Center, Randomized, Double Blind, Placebo-Controlled Clinical Trial," were presented by Irwin Goldstein, MD, clinical professor of surgery, University of California, San Diego and director of sexual medicine at Alvarado Hospital, San Diego, California. The presentation marks the first time these results have been shared with the medical community at a major medical meeting.
The REVIVE study met all primary endpoints across the three doses studied by demonstrating statistically significant improvements in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the International Index of Erectile Function (IIEF) score. Successful intercourse was also reported in as little as 15 minutes and beyond six hours in subjects who attempted intercourse at those time points. Avanafil was well tolerated and demonstrated a favorable side-effect profile with low rates of typical PDE5 inhibitor-like adverse events.
"Many men living with ED often become frustrated by the side effects associated with currently available therapies, or by the length of time it takes for their ED therapy to become effective. Patients are continually in search of treatment options which may help provide a more satisfactory experience in less time," stated Dr. Goldstein. "The efficacy and safety seen with avanafil in this 'real world' study setting is impressive, and its fast onset of action and sustained activity differentiates this PDE5 inhibitor from other therapies. I am encouraged by these results, and the potential role avanafil may play in the lives of men living with chronic ED."
Highlights of the pivotal study, conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA), include:
- Nearly 80% of all sexual attempts among patients on the 200 mg dose of avanafil had erections sufficient for intercourse (SEP2)
- Treatment with avanafil significantly improved erectile function in a dose-dependent manner; the percentage of subjects achieving a normal IIEF-EF domain score was greater across all doses of avanafil compared to placebo
- Successful intercourse was reported by avanafil patients attempting intercourse in 15 minutes or less and beyond six hours in patients attempting intercourse at those time points
- There were no drug-related serious adverse events in the study
- Avanafil patients reported low frequency of common PDE5i side effects
"More than half of all men over the age of 40 are living with ED, yet research shows that men are dissatisfied with currently available PDE5i therapies," stated Leland Wilson, chief executive officer of VIVUS. "We are honored to have Dr. Goldstein to be the first to share these results with the urology community and look forward to filing an NDA in the first half of 2011."
The most commonly reported side effects in patients taking avanafil included headache, flushing and nasal congestion.
About the Study
REVIVE (TA-301) was a randomized, double-blind, placebo-controlled phase 3 study of avanafil in 646 men with a history of generalized ED. On average patients had ED for at least six years and 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, 100mg and 200mg or placebo. Patients were instructed to wait 30 minutes before attempting sexual intercourse 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 Erectile Function Domain score of the International Index of Erectile Function (IIEF) score. Secondary endpoints included patient satisfaction with erections and with sexual experience.
REVIVE is the first of four phase 3 avanafil trials. Additional phase 3 studies include treatment in diabetic males with ED (REVIVE-Diabetes or TA-302) and in males with ED following a post-radical prostatectomy (TA-303). Last year, VIVUS also initiated an open-label safety study (TA-314) evaluating the long-term safety and tolerability of avanafil as part of its path toward NDA filing. TA-314 is being conducted over one year in approximately 700 patients across 40 U.S. centers. Patients completing either the 12-week REVIVE or REVIVE-Diabetes studies were eligible to participate in TA-314. Results of the study are expected to be available by late-2010.
Avanafil is a second-generation, highly selective oral phosphodiesterase type 5 (PDE5) inhibitor therapy being investigated for the treatment of ED. Studies to date have demonstrated that avanafil has an onset of action in approximately 30 minutes, with activity apparent in 15 minutes or less after administration. The unique profile of avanafil suggests that the compound may be more selective than other PDE5 inhibitors, potentially resulting in lower incidence of the side effects most commonly associated with currently available PDE5 inhibitor therapies.
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.
VIVUS is a biopharmaceutical company developing innovative, therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health. The company's lead product in clinical development, Qnexa®, has completed phase 3 clinical trials for the treatment of obesity and an NDA has been filed and accepted by the FDA, with an action date of 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 male sexual health, VIVUS is in phase 3 development with avanafil, a potentially best-in-class PDE5 inhibitor for the treatment of erectile dysfunction. MUSE® (alprostadil), a first generation therapy for the treatment of ED, is already on the market and generating revenue for VIVUS. 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," "estimated" and "intend," among others. These forward-looking statements are based on VIVUS' current expectations and actual results could differ materially. 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, substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be completed or successful 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 statement. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2009 and periodic reports filed with the Securities and Exchange Commission.
The Trout Group
Timothy E. Morris
Chief Financial Officer
Pure Communications, Inc.
SOURCE VIVUS, Inc.