Vivus reported positive data from two pivotal Phase III trials with its weight-loss drug, Qnexa™. It says that the results exceeded FDA efficacy benchmarks at all doses tested. The company confirmed its intention to file an NDA by the end of 2009. Partnering discussions are also in the planning.
Vivus stock jumped over 58% to open the day at $10.95. The stock rose as high as $12.48 in early morning trading.
Qnexa is a once-daily, controlled-release formulation of low-dose phentermine and topiramate. The year-long placebo-controlled trials, Equip (OB-302) and Conquer (OB-303), evaluated different doses of Qnexa in over 3,500 overweight, obese, and morbidly obese patients. All patients were also asked to follow a hypocaloric diet.
Results from Equip, which included 1,267 morbidly obese patients, showed that participants taking the full dose of Qnexa lost an average of 37 pounds, equivalent to 14.7% of their body weight. In comparison, placebo-group patients lost six pounds on average. Sixty percent of full-dose Qnexa patients who completed the study lost at least 10% of their baseline weight, with 43% losing at least 15% of their body weight. Patients given full-dose Qnexa also demonstrated significant improvements in blood pressure as well as triglyceride and cholesterol levels.
The Conquer study included 2,487 overweight and obese patients with high blood pressure, high cholesterol, or type 2 diabetes. Their average baseline weight was 227 pounds. Weight loss among participants given full-dose Qnexa who completed the trial was 30 pounds compared with a six pound weight loss achieved by placebo patients. Sixty four percent of the full-dose patients who completed the study lost at least 10% of their baseline weight, and 39% lost at least 15% of baseline weight.
Higher-risk patients who received full-dose Qnexa also achieved an average 20 mmHh reduction from baseline in systolic blood pressure even when they had their blood pressure medications reduced. There was an average drop in patients’ triglyceride levels of 98 mg/dL from baseline and a reduction in haemoglobin A1c levels of 0.6% from 7.3% at baseline.
Lead investigator, Kishore Gadde, M.D., director of obesity clinical trials at Duke University, says that the weight loss observed in the two trials “far exceeds the weight loss observed for other agents reported in the literature.”
Michelle Look M.D., FAAFP, lead investigator at the San Diego sports medicine and family health center, concurrs. “I have seen a dramatic and sustained weight loss with Qnexa as well as notable improvements in cardiovascular risk factors, diabetes, emotional well-being, and quality of life in my patients. What is so striking is how many of my patients were able to achieve weight loss with Qnexa for the first time after many years of battling weight problems without success.”