FDA approves new weight loss pill Contrave
11 September 2014
US drug regulator, the FDA yesterday approved a new weight-loss pill called 'Contrave', www.upi.com reported. The pill, made by Orexigen Therapeutics Inc, San Diego, would be marketed by Takeda Pharmaceutical of Japan.
The FDA had earlier approved two pills - Qsymia and Belviq - that are already in the market. The pills help adults manage their weight.
In a press release, the FDA said Contrave was approved for adults with a BMI of 27 or greater (overweight) with an accompanying weight-related condition like high blood pressure, type 2 diabetes or high cholesterol or a BMI of 30 or greater (obesity).
According to the FDA's Jean-Marc Guettier, "When used as directed in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, Contrave provides another treatment option for chronic weight management for people who are obese or are overweight and have at least one weight-related health condition."
Contrave combines two FDA approved drugs, naltrexone and bupropion. Naltrexone is approved for the treatment of alcohol and opioid dependence while Bupropion is approved to treat depression and seasonal affective disorder. It is also approved as an aid to smoking cessation treatment.
All of the new drugs work by decreasing appetite and come with side effects and drawbacks, but do not promise massive weight loss, USA Today reported.
"Obesity continues to be a major public health concern," Guettier said in the press release. "When used as directed in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, Contrave provides another treatment option."
Contrave would, however, come with a warning that it might increase suicidal thoughts, and other possible side effects, including increases in blood pressure and heart rate, according to the FDA.
In trials, patients taking Contrave lost 2 per cent to 4.1 per cent more weight than those taking placebo and between 36 per cent and 42 per cent lost at least 5 per cent of their body weight.
In Belviq's studies for the FDA, average losses were 3 per cent to 3.7 per cent, over placebo. For Qsymia, average losses ranged from 6.7 per cent to 8.9 per cent over placebo.
According to Adam Tsai, a Denver internist who chairs the public affair committee of the Obesity Society, a group representing weight loss experts, such weight losses could be meaningful, but they would not happen if consumers relied on pills alone.
The ideal candidate for a drug to treat obesity was someone who used the drug as a tool, along with diet and exercise, he added.