Takeda Pharmaceuticals USA and Orexigen Therapeutics have received approval from the US Food and Drug Administration (FDA) for a new weight-loss pill called Contrave (naltrexone HCI and bupropion HCI).
The approval allows the tablets to be used for chronic weight management in adults with an initial body mass index (BMI) of 30kg/m2 or greater (obese), or 27kg/m2 or greater (overweight).
Contrave comprises two component in naltrexone, an opioid blocker used to stop alcohol and opioid addiction; and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine and an active ingredient in the antidepressant Wellbutrin.
Takeda Pharmaceuticals USA president Douglas Cole said: “The FDA approval of Contrave is a significant milestone in Takeda’s and Orexigen’s commitment to leading innovation in medicine for patients and physicians dealing with chronic conditions and diseases, such as obesity.
“It’s important that physicians and appropriate patients have options when discussing weight management, especially when you look at the prevalence of obesity in today’s society. We’re excited about the addition of Contrave to our Cardiovascular and Metabolic Disease Portfolio.”
Both companies agreed to several post-marketing requirements, including studies to assess the safety and efficacy of Contrave for weight management in obese pediatric patients, as part of the approval process.
To evaluate the efficacy of Contrave, four 56-week multicentre, double-blind, placebo-controlled obesity trials were conducted on 4,536 patients, which demonstrated a percent change from baseline in body weight and a decrease in body weight of around 5%.
However, the FDA cautioned: “Contrave can cause seizures and must not be used in patients who have seizure disorders. Contrave can also raise blood pressure and heart rate and must not be used in patients with uncontrolled high blood pressure.”
The drug should also not be used in patients who have eating disorders, such as bulimia or anorexia nervosa, the FDA said.
Another clinical trial, LIGHT study, is also being planned by the companies to evaluate the occurrence of major adverse cardiovascular events in overweight and obese adults with cardiovascular risk factors receiving Contrave.
The tablets are expected to be commercially launched towards the end of 2014, and are recommended to be used along with a low-calorie diet and exercise regimen.
Contrave is said to be the third weight loss drug approved by the FDA in recent years.