Takeda and Orexigen’s Weight Loss Drug Gets FDA Green Light
The FDA has cleared Takeda and Orexigen Therapeutics’ weight-loss drug Contrave, the first new anti-obesity product to win approval in more than two years.
The drug, which combines extended-release naltrexone HCl and bupropion HCl, is indicated with diet and exercise for adults with body mass index over 27, and who have high blood pressure, high cholesterol or type 2 diabetes.
Both active ingredients have been approved for separate conditions: naltrexone for alcoholism and opioid dependence, and bupropion for seasonal affective disorder and smoking cessation.
Contrave won approval based on clinical trials of more than 4,530 overweight patients with and without weight-related health problems. In one trial, patients without type 2 diabetes who were given Contrave lost 4.1 percent more body weight than did patients on placebo. In a second trial, patients with type 2 diabetes lost 2 percent more body weight than patients on placebo.
The FDA has instituted several postmarket trial requirements on the drug, including assessments of cardiovascular risks, drug interactions, pediatric safety, and dosing in patients with impaired liver or kidney function.
Contrave is the first weight-loss drug approved since 2012 when the FDA cleared Vivus’ Qsymia (phentermine/topiramate) and Arena Pharmaceutical’s Belviq (lorcaserin HCl). — Lena Freund
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.