VIVUS Initiates Open Label Safety Study Of Avanafil For Erectile Dysfunction

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 14 May 2009 - 1:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

VIVUS, Inc. (Nasdaq: VVUS), a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health, announced that it has initiated an open label safety study (TA-314) with its investigational drug, avanafil, in males with erectile dysfunction (ED).

VIVUS also announced today that it has completed enrollment in REVIVE (TA-301), a randomized, double-blind, placebo-controlled phase 3 study of avanafil in men with a history of generalized ED and the first of several planned phase 3 studies of avanafil. Approximately 650 patients have been enrolled in the study. Top-line results of REVIVE are expected in the fourth quarter of 2009.v Avanafil, a next-generation, fast-acting, selective, oral, phosphodiesterase type 5 (PDE5) inhibitor, is VIVUS' investigational product for the treatment of ED. The phase 3 program for avanafil is funded through a $30 million collaboration with Deerfield Management.

"We continue to make excellent progress on the avanafil phase 3 program, and are pleased with the rapid rate at which we accrued patients in our first pivotal study, REVIVE," commented Charles Bowden, MD, senior director of clinical development at VIVUS. "Initiation of the TA-314 safety study is a critical step in advancing avanafil toward an NDA filing. We are confident that avanafil will provide a much needed new option for the millions of men living with ED, and we look forward to announcing data from both of these studies later this year and next."

The open-label study is being conducted in approximately 600 patients across 40 U.S. centers. Patients completing either the 12-week REVIVE or REVIVE-Diabetes studies are eligible to participate in TA-314. The goal of the TA-314 study is to collect safety data on at least 300 patients for 6 months and at least 100 patients for 12 months. Results of the TA-314 study are expected to be available by mid-2010.

"Initiation of the avanafil safety study is an important step in the development of the drug and demonstrates continued momentum at VIVUS," added Leland Wilson, president and chief executive officer of VIVUS. "We're very pleased with the progress we have made across our entire pipeline. We look forward to several significant milestones in the second half of this year, including results from two phase 3 obesity trials of our lead product Qnexa as well as data from the REVIVE trial of avanafil and participation in several upcoming medical meetings."

About VIVUS

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), is expected to complete phase 3 clinical trials for the treatment of obesity in 2009. 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(R) (alprostadil), a first generation therapy for the treatment of ED, is already on the market and generating revenue for VIVUS.

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, 2008 and periodic reports filed with the Securities and Exchange Commission.

Source: VIVUS, Inc