Will Experimental Weight Loss Drug Gain FDA Approval?

weight loss pillsScienceDaily recently published an article about an investigational combination of drugs already approved to treat obesity, migraine and epilepsy that produced up to a 10 percent weight loss in obese individuals participating in a one-year clinical trial. The participants of this Duke University Medical Center study took a controlled-release combination therapy consisting of phentermine and topiramate. Patients receiving this combination experienced on average 8.6 percent greater weight loss compared to those patients receiving placebo. They also saw reductions in blood pressure and improvements in cholesterol, triglycerides and inflammatory markers.

Currently, there is only one drug on the market for long-term treatment of obesity – orlistat. It is known as Xenical in prescription strength and over the counter as Alli. According to the article, studies have shown that treatment with orlistat can lead to about seven-pound greater weight loss compared to treatment with placebo after one year, but the combination drug achieves about 19 pounds of weight loss relative to placebo at one year.

Dr. Kishore M. Gadde, M.D., who is the director of Duke’s obesity clinical trials program, believes more treatments are needed for obesity as rates increase. “Two thirds of Americans are overweight or obese. For obese patients who have failed to achieve meaningful weight loss with diet and exercise, we have just one treatment before jumping to bariatric surgery. We need more treatment options.”

However, weight loss drugs are difficult to get approved – partially because it is hard to determine if a drug is medically safe enough for 2 out of 3 Americans to use.  Last month, MedPage Today published an article about obesity experts meeting with the head of the FDA’s drug division to discuss a way forward for weight-loss drugs. This meeting took place after the agency rejected three weight loss drugs in the past six months. The FDA requires diet drugs to show in clinical trials that at least 30% of people who took the drug lost at least 5% of their body weight.  Additionally, after one year, the difference in average weight loss between the active and control groups needs to be at least 5%.

One of the obesity experts at the meeting, Louis Aronne, MD, who is a clinical professor at Weill Medical College and director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital, explained: “We should be really looking at the complications of obesity and how it’s affecting health. If we focus more on the complications that we associate with obesity, then the benefits would be clear. In addition, obesity drugs could then be approved for a smaller subgroup of obese people in whom they’ve been shown to have a measurable impact on weight-related comorbidities.”

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