VIVUS, Inc. Initiates Pivotal Phase 3 Trial in Obese Patients and Announces Qnexa Dose

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced that it has initiated the first of two pivotal phase 3 studies of Qnexa in obese patients. The EQUIP study (OB-302) will enroll morbidly obese patients with Body Mass Index (“BMI”) that equals or exceeds 35. The co-primary endpoints for these studies will evaluate the differences between treatments from baseline to the end of the treatment period, in mean percent weight loss and in the percentage of subjects achieving weight loss of 5% or more. All phase 3 studies will utilize the company’s novel once-a-day formulation of Qnexa, which at full strength, contains 15 mg phentermine IR and 92 mg topiramate CR. PK/PD studies have confirmed that the once-a-day formulation is comparable to the twice-a-day formulation used in the phase 2 study.