Qnexa® Phase 3 Data Published In Obesity Show 14.4% Average Weight Loss In Severely Obese Patients Completing One Year Of Treatment
Weight Loss Accompanied by Improvements in Cardio-Metabolic Risk Factors
MOUNTAIN VIEW, Calif., Nov. 3, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that results from the 56-week EQUIP study were published in Obesity, the peer-reviewed journal of The Obesity Society. The EQUIP study evaluated the efficacy and safety of the investigational drug Qnexa in 1,267 severely obese (BMI >/= 35 kg/m2) patients across 91 sites in the US. In addition to average weight loss of 14.4% of initial body weight among those who completed the study at the top dose of Qnexa, severely obese patients had improvements in blood pressure, glucose, triglycerides and cholesterol. The results with Qnexa suggest the potential to effectively treat severely obese patients without surgery.
"Obesity is a serious medical condition that threatens the public health and reduces the quality and length of lives. Currently available treatments are limited and options are needed," said lead investigator Dr. David Allison, director of the Nutrition Obesity Research Center, University of Alabama at Birmingham. "In this population of severely obese patients, those taking Qnexa experienced significant weight loss and reduction in risk factors for many chronic diseases. The results refute a common notion that nonsurgical treatments are not effective for extremely obese persons. The findings are especially relevant to the 14% of the US adult population classified as extremely obese."
Patients in the study had a baseline body mass index of >/= 35 kg/m2, and an average initial weight of 256 pounds. Treatment was well tolerated, with no evidence of serious adverse events induced by treatment.
Specific weight loss results for all patients through 56 weeks as published in Obesity are as follows:
- Least-squares (LS) mean weight loss for Qnexa patients who completed the EQUIP study was 14.4% and 6.7% with top-dose Qnexa and low-dose Qnexa, respectively, compared to 2.1% in the placebo group (p<0.0001);
- In the ITT-LOCF analysis, LS mean percent weight loss at week 56 was 10.9%* and 5.1%* for the top and low dose, respectively, as compared to 1.6% for the placebo group (p<0.0001);
- Among patients who completed the top-dose course of treatment, 83.5% lost >/= 5%; 67.7% lost >/= 10%; and 48.1% lost >/= 15% of their baseline weight;
- Categorical weight loss from baseline (ITT-LOCF) was:
*p<0.0001 vs placebo
+p < 0.05 vs placebo
A significantly greater number of patients completed one year of treatment in the Qnexa groups, top dose (66%) and low dose (61%), as compared to the placebo group (53%). The most commonly reported side effects were tingling, dry mouth, constipation and altered taste. Rates of serious adverse events were the same across treatment groups. Most adverse events were seen early in treatment and there was a low dropout rate due to adverse events, 16.0% and 11.3% for top and low dose, respectively, compared to 8.4% for placebo.
About the EQUIP Study
The EQUIP study included 1,267 severely obese patients (1,050 females and 217 males) with an overall mean age of 42.7 years; mean BMI of 42.0 kg/m2; and mean baseline weight of 256 pounds. Eligibility criteria included age 18-70 years; BMI >/= 35 kg/m2 (no upper limit); triglycerides
The study was a randomized, double-blind, placebo-controlled, 3-arm, prospective trial with patients randomized to receive once-a-day treatment with low-dose Qnexa, top-dose Qnexa or placebo. 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 Capsules
Qnexa [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.
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 development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS has submitted an NDA for avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction. For more information about the company, please visit www.vivus.com.