Within this year Food and Drug Administration (FDA) advisory panel has rejected two weight loss drugs, named Qnexa (phentermine/topiramate) and Loracserin (lorcaserin hydrochloride). Another weight loss drug that has been facing the advisory panel discussions since Tuesday, has finally received blessings from the FDA. FDA advisory panel has voted 13-7 in favor of approving a new medication which is aimed at aiding people in losing weight and maintaining that weight loss.
The drug in question, Contrave, was developed by La Jolla, California-based Orexigen Therapies in partnership with Takeda. The drug is now pretty close to becoming the first new weight-loss medication to receive FDA approval in over a decade. The FDA’s decision is due by Jan. 31.
Contrave is a combination of two drugs, Bupropion, commonly prescribed to treat depression and smoking cessation and naltrexone approved to treat opioid and alcohol addictions. Both of these drugs have been on the market individually for about 25 years. Contrave is seeking approval for treatment of obesity and weight management in patients with a body mass index of 30 or above; or 27 or above and with one or more risk factors, such as diabetes, dyslipidemia or hypertension.
FDA Advisory Panel discussions and opinions
The Endocrine and Metabolic Drugs Advisory Committee reviewed the results of four placebo-controlled, one-year, phase III clinical trials conducted by Orexigen. The study enrolled 3,200 obese patients with at least one comorbid condition, including diabetes and depression. In all four trials, patients on the naltrexone/bupropion combination lost more weight than those in the placebo group (P<0.001), and more than 30% lost at least 5% of their body weight, which is one of the crucial standards by which the FDA judges efficacy of weight-loss drugs.
In regard to safety of the drug, reviewers expressed concerns over several side effects associated with naltrexone/bupropion combination – a potential increased risk for dizziness, nausea, seizures, and high blood pressure. However, the panel was mostly just concerned with the drug’s effect...
on blood pressure.
The denial of Qnexa and Loracserin happened due to heart-related side effects, and the FDA asked Abbott Laboratories, the maker of another anti-obesity drug sibutramine (Meridia), to pull their drug from store shelves two months ago because of increased risk of stroke and MI.
“I am most distressed about this particular adverse effect,” said committee member Jules Hirsch, MD, of Rockefeller University in New York City. “There needs to be very, very careful attention if this drug is approved.”
Dietitian Connie Diekman, director of University Nutrition at Washington University in St Louis said “It is nice to have a medication that can help those who are watching their diet and boosting activity lose the weight that thus far has been a slow process.”
Dr. Robert F. Kushner, professor of Medicine at Northwestern University Feinberg School of Medicine said “I fully endorse the panel’s vote. The key will be to educate physicians on how to best prescribe the medication — identify patients who will benefit from the medication and to accompany it with lifestyle and behavioral recommendations.”
There is currently just one anti-obesity drug on the market- Orlistat (Xenical, Alli). No doubt that health professionals have been looking to welcome another drug aiming to reduce the weight of their patients. After getting approval from the FDA advisory panel, the drug has secured it’s place in this round and is closed to get final approval from the FDA. In my view, since obesity and other associated co-morbid conditions are long term conditions, time will be a better judge to evaluate the safety and efficacy of the drug.