ARTICLE | Top Story

More Qnexa safety data

September 21, 2010 11:34 PM UTC

Shares of Vivus Inc. (NASDAQ:VVUS) gained on Tuesday after the company reported data from the SEQUEL (OB-305) extension study of Qnexa phentermine/topiramate that may address some of the concerns raised by an FDA panel that recommended against approval of the obesity candidate. The double-blind, 52-week extension study enrolled 675 obese or overweight patients who completed the 56-week Phase III CONQUER trial. At 108 weeks, rates of treatment-emergent serious adverse events were 2.6% and 4.1% for mid- and high-dose Qnexa vs. 4% for placebo, with no drug-related serious adverse events reported. There was no evidence of suicidality and no reports of suicidal attempts or behavior. Depression assessments as measured by the PHQ-9 clinical depression scale improved from baseline for all treatment groups.

Furthermore, Vivus said that the effects of Qnexa on heart rate were small and observed in conjunction with improvements in blood pressure from baseline. Both doses of once-daily oral Qnexa also met the extension study's co-primary endpoints of mean percentage weight loss from baseline and percentage of patients achieving at least 5%, 10% and 15% weight loss vs. placebo at 108 weeks. ...