Weight loss drug Qnexa submitted to the FDA for approval
Written By Betty van der Mark on Wednesday, December 30, 2009 | 8:08 AM
The Phase 3 clinical program evaluated Qnexa in more than 4,500 patients in the randomized, double-blind, placebo-controlled trial. The average baseline weight in one trial was 223 pounds and another trial had an average baseline weight of 256 pounds. All patients were asked to follow a diet representing a 500-calorie/day deficit and advised to implement a simple lifestyle modification program. "The weight loss of up to 37 pounds combined with significant improvements in weight-related medical conditions, such as hypertension and diabetes, demonstrates the importance of treating obesity, which has become a major epidemic in the United States," Leland F. Wilson, chief executive officer for Vivus, said in a statement. Across both 56-week studies, the most commonly reported side effects were dry mouth, tingling and constipation, the application said.