Qnexa Meets Primary Endpoint By Demonstrating Superior Weight Loss Over Components And Placebo In The 28-Week Equate Study (OB-301)

Qnexa Meets Primary Endpoint By Demonstrating Superior Weight Loss Over Components And Placebo In The 28-Week Equate Study (OB-301)
15 Dec 2008 - 4:00 PST
Medicalnewstoday.com

VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced positive results from the EQUATE study (OB-301), a 28-week, phase 3 obesity trial conducted at 32 sites with Qnexa™, an investigational drug. The EQUATE study met the primary endpoint by demonstrating superior weight loss with both the full-dose and mid-dose of Qnexa, as compared to the individual components and placebo. Subjects treated with full-dose and mid-dose Qnexa had an average weight loss of 9.2% and 8.5% respectively, as compared to weight loss of 1.7% reported in the placebo group (ITT LOCF p<0.0001). Average weight loss was 19.8 pounds and 18.2 pounds in the treatment arms as compared to 3.3 pounds in the placebo group. Qnexa was well-tolerated, with no drug-related serious adverse events in the study.

"The results from the EQUATE trial once again confirmed our belief in Qnexa. In addition to hitting the primary endpoints of the study with the full-dose, we were also able to show excellent results with the mid-dose of Qnexa," commented Leland Wilson, president and chief executive officer of VIVUS. "The EQUATE study is the first of three studies in the Qnexa phase 3 obesity program. Data from the EQUIP and CONQUER studies, which combined enrolled over 3,750 subjects, is expected in mid-2009."

The EQUATE study included 756 obese subjects (599 females and 157 males) across 32 centers in the United States. The average baseline BMI of the study population was 36.3 kg/ m2 and baseline weight was 223 pounds. The proportion of patients losing 5% or more of their initial body weight was 66% for full-dose, 62% for mid-dose and 15% for placebo (p<0.0001). The proportion of patients losing 10% or more of their initial body weight was 41% for full-dose, 39% for mid-dose and 7% for the placebo group (p<0.0001).

The most common drug-related adverse events reported for the full-dose, mid-dose and placebo group were paresthesia (20%, 15%, 3%), dry mouth (18%, 12%, 0%), altered taste (15%, 8%, 0%) and constipation (11%, 6%, 6%). Reported drug related adverse events for depression and altered mood were minimal (1.9%, 0.9% and 1.8% respectively). Moreover, individual depression assessments for each subject, as measured by PHQ-9, demonstrated statistically significant improvements (p<0.05) from baseline for both Qnexa treatment groups. Overall average completion rate for the Qnexa treatment group was 71%.

Subjects in the EQUATE study had a 4-week dose titration period followed by 24 weeks of treatment. The study was a randomized, double-blind, placebo-controlled, 7-arm, prospective trial with subjects randomized to receive once-a-day treatment with mid-dose Qnexa (7.5 mg phentermine/46 mg topiramate CR), full-dose Qnexa (15 mg phentermine/92 mg topiramate CR), the respective phentermine and topiramate constituents, or placebo. Subjects were asked to follow a hypocaloric diet representing a 500-calorie/day deficit and advised to implement a simple lifestyle modification program.

About the Qnexa Phase 3 Obesity Program
In addition to the EQUATE study, the phase 3 Qnexa program includes two pivotal, double-blind, placebo-controlled, multi-center studies that will compare the efficacy and safety of Qnexa to placebo during a 56-week treatment period. The first year long study, known as EQUIP (OB-302), has enrolled approximately 1,250 morbidly obese adult subjects with a Body Mass Index (BMI) of 35 or greater with or without controlled co-morbidities. The second trial, known as CONQUER (OB-303), has enrolled overweight and obese adult subjects with BMIs from 27 to 45 and at least two co-morbid conditions, such as hypertension, dyslipidemia and type 2 diabetes. The co-primary endpoints for these studies are the mean percent weight loss and the percentage of subjects achieving a weight loss of five percent or more. Results from these studies are expected mid-2009. In total the phase 3 program has enrolled approximately 4,500 subjects.

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