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. 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."
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Experts claim that patients can lose as much weight with Qnexa as they would if they had obesity surgery. Dr Kishore Gadde, director of obesity clinical trials at Duke University in North Carolina, who led the study, said: “The weight loss observed with Qnexa in these trials far exceeds the weight loss observed for other agents reported in literature.”
