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Qnexa® Phase 3 Data Published In Obesity Show 14.4% Average Weight Loss In Severely Obese Patients Completing One Year Of Treatment
Date:11/3/2011

Patients had a 4-week dose titration period followed by 52 weeks of treatment. Throughout the 56-week treatment period, all patients were advised to follow a modest lifestyle modification program including reduction of food intake by 500 calories per day. Primary efficacy analyses included pre-specified ITT-LOCF (Intent-to-Treat with Last Observation Carried Forward) including all randomized patients who received at least one dose of drug/placebo and had at least one post-randomization weight measurement; and "Completers Only," which included all randomized patients who had a week 56 measurement and received at least one dose of drug/placebo treatment within 7 days of their week 56 measurement.

About Qnexa Controlled-Release CapsulesQnexa [kyoo-nek-suh] is an investigational drug candidate being developed to address weight loss, type 2 diabetes and obstructive sleep apnea. Qnexa is a once-a-day, proprietary, oral, controlled-release formulation of low-dose phentermine and topiramate, which is designed to decrease appetite and increase satiety (the sense of feeling full), the two main mechanisms that impact eating behavior. In phase 2 and 3 clinical data to date, patients taking Qnexa have demonstrated statistically significant weight loss, glycemic control and improvement in cardiovascular risk factors, when used in combination with a diet and lifestyle modification program.

About VIVUS 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. VIVUS has resubmitted an NDA for Qnexa, with an FDA action date of April 17, 2012. Qnexa is also in phase 2 clinical de
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SOURCE VIVUS, Inc.
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3. Weight Loss With QNEXA® Over Two Years Provides Patients With Substantial Cardiovascular Benefits
4. Long-Term Data on QNEXA® to be Presented at The American College of Cardiology Annual Meeting
5. VIVUS Submits Briefing Document to FDA, Announces Follow-up Meeting to Discuss QNEXA®
6. FDA Issues Complete Response Letter to VIVUS Regarding New Drug Application for QNEXA®
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