MOUNTAIN VIEW, Calif., Dec. 29 (UPI) -- A California biopharmaceutical company has submitted a government application for a new weight-loss drug, officials said Tuesday.
Officials at Vivus, Inc., said it has submitted a new drug application to the U.S. Food and Drug Administration for approval of Qnexa for the treatment of obesity, including weight loss and maintenance of weight loss.
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.
