Vivus presents positive results from obesity drug study

The DM-230 study met its primary endpoint of demonstrating glycemic control as measured by a reduction of hemoglobin A1c (HbA1c) of 1.6% from 8.8% to 7.2% for subjects treated with Qnexa, as compared to 1.1% from 8.5% to 7.4% in the placebo group (ITT LOCF p=0.0381) at 56 weeks.

The DM-230 study was designed as a continuation study to the OB-202 diabetes study. The OB-202 study was a 28-week, randomized, double-blind, placebo-controlled, efficacy and safety study of Qnexa in the glycemic management of 206 obese type 2 diabetics.

The DM-230 study enrolled 130 subjects at 10 study sites completing OB-202 to continue, in a blinded fashion as previously randomized for an additional 28 weeks. The results of the DM-230 study include assessments from the start of the OB-202 study through the end of the DM-230 study in this population, for a total treatment period of 56 weeks.

According to the company, fasting plasma glucose levels were reduced in subjects treated with Qnexa from 176mg/dL to 133mg/dL, as compared to a decrease from 171mg/dL to 145mg/dL for the placebo group (p=0.02). Over 56 weeks subjects treated with Qnexa also lost 9.4% of their baseline body weight, or 20.5 pounds, as compared to 2.7%, or 6.1 pounds, for the placebo group (p<0.0001). Subjects treated with Qnexa had reductions in blood pressure, triglycerides and waist circumference. Both treatment groups had a study completion rate greater than 90%.

Leland Wilson, president and CEO of Vivus, said: The results from DM-230 confirm our belief that Qnexa may be an appropriate treatment for type 2 diabetes given the reduction in HbA1c of 1.6% combined with weight loss of 9.4% seen in the most recent study. Historically, diabetic patients have a difficult time losing weight. With Qnexa, patients were able to lose over 20 pounds and importantly keep it off throughout the 56 week study with no rebound.