MOUNTAIN VIEW, Calif., Jan. 6 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS) plans to announce the results from a phase 2 study evaluating the safety and efficacy of Qnexa, for the treatment of obstructive sleep apnea (OSA), on January 7th prior to market open. The announcement will be followed by a webcast and conference call at 8:30 a.m. Eastern time.
Conference Call Information
Domestic callers: 1- 888-806-6202
International callers: 1- 913-312-6680
Webcast information: http://ir.vivus.com. A webcast replay will be available on the VIVUS web site for 30 days.
About the Sleep Apnea (OB-204) Study
The phase 2 study (OB-204) was a single-center, randomized, double-blind, placebo-controlled parallel group trial including obese men and women (BMI 30 to 40 kg/m2 inclusive), 30 to 65 years of age with OSA (apnea/hypopnea index greater than or equal to 15) at baseline, who had not been treated with, or who were not compliant with continuous airway pressure (CPAP) devices within three months of screening. Patients were randomized to placebo or full-dose Qnexa. Patients underwent a four-week dose titration followed by 24 weeks of additional treatment. All patients were also provided with a lifestyle modification program focusing on diet and exercise. Overnight polysomnography was performed at baseline, Week 8 and Week 28. The primary endpoint was the change in Apnea/Hypopnea Index (AHI) between baseline and Week 28; secondary endpoints included weight loss, oxygen saturation and changes in blood pressure.
About Obstructive Sleep Apnea (OSA)
Obstructive sleep apnea (OSA) is a sleep-related breathing disorder that involves a decrease or complete halt in airflow despite an ongoing effort to breathe. Approximately 18 million Americans are living with OSA, though an estimated 90 percent of patients remain undiagnosed or untreated. Studies have identified a relationship between OSA and a number of cardiovascular and metabolic diseases including hypertension, diabetes, stroke, congestive heart failure and sudden cardiac death. Currently, there are no pharmacotherapy agents approved to treat sleep apnea. More information on sleep apnea can be found on the American Academy of Sleep Medicine website at: http://www.aasmnet.org/Resources/FactSheets/SleepApnea.pdf
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®, has completed phase 3 clinical trials for the treatment of obesity and an NDA was submitted to the FDA in December 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 for the treatment of erectile dysfunction, and in phase 2 development of Luramist(TM) for the treatment of hypoactive sexual desire disorder (HSDD) in women. 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.
CONTACT: -------- VIVUS, Inc. Timothy E. Morris Chief Financial Officer 650-934-5200 Investor Relations: The Trout Group Brian Korb 646-378-2923 Media Relations: Pure Communications, Inc. Dan Budwick 973-271-6085
SOURCE VIVUS, Inc.