VIVUS Announces Qnexa Quality of Life Data at the Obesity Society's 2007 Annual Scientific Meeting
The study examined the impact of weight loss achieved with Qnexa (a novel combination therapy of topiramate and phentermine) on quality of life in obese patients. Weight-related Quality of Life (QOL) was assessed using the Impact of Weight of Life-Lite (IWQOL-Lite(C)) questionnaire. IWQOL-Lite is a validated, patient reported measure of weight-related quality of life that provides assessments on physical function, self-esteem, sexual life, public distress and work.
Patients treated with Qnexa had significantly greater improvements than the topiramate and placebo groups in the physical function, self-esteem and public distress domains, with the greatest improvement occurring in self-esteem. Although all the study groups reported weight loss, the study showed that patients treated with Qnexa and phentermine alone had greater improvements in quality of life than placebo or topiramate alone. Topiramate treatment yielded more weight loss than phentermine, but without any appreciable improvements on QOL. This suggests that phentermine in the presence of topiramate may play an important role in enhancing the tolerability of topiramate.
"Numerous studies have shown that obesity is associated with decreased health- and weight-related quality of life," commented Dr. Wesley Day, vice president of Clinical Development for VIVUS. "These results support our hypothesis regarding the complementary pharmacology of the phentermine and topiramate combination. We've already shown data indicating that phentermine in the presence of topiramate provides a significant enhancement of weight loss and associated benefits on comorbidities compared to topiramate alone. These results further demonstrate that the benefits of phentermine in the presence of topiramate are not just achieving greater weight loss but also providing significant improvements in meaningful QOL endpoints.
About VIVUS
VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of next-generation therapeutic products addressing obesity and sexual health. VIVUS has three products that are positioned to enter Phase 3 clinical trials, and one product currently under NDA review by the FDA. The pipeline includes: Qnexa, for which a Phase 2 study has been completed for the treatment of obesity; Testosterone MDTS(R), for which a Phase 2 study has been completed for the treatment of Hypoactive Sexual Desire Disorder (HSDD); EvaMist(TM), for which a Phase 3 study has been completed and an NDA submitted for the treatment of menopausal symptoms; and avanafil, for which a Phase 2 study has been completed for the treatment of erectile dysfunction (ED). MUSE(R) is approved and currently on the market for the treatment of ED. For more information on clinical trials and products, please visit the company's web site at www.vivus.com.
(C)Copyright 2000 by Duke University Medical Center. All Rights Reserved.
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, the risk that sales of Evamist may never reach the stated sales milestones to trigger the payment of additional consideration; 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; the pivotal trial design, the number of patients required and cost estimates to complete all the necessary studies of Qnexa 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, 2006 and periodic reports filed with the Securities and Exchange Commission.
Contact
VIVUS, Inc.
Timothy E. Morris, 650-934-5200
Chief Financial Officer
or
The Trout Group
Ian Clements (SF), 415-392-3385
or
Brian Korb (NYC), 646-378-2923
Posted: October 2007
