The FDA has finally approved the use of Contrave (naltrexone hydrochloride and bupropion hydrochloride tablets), manufactured by Orexigen Therapeutics, for chronic weight management. The regimen includes taking the drug coupled with physical activity and a reduced calorie diet.1
The fourth obesity drug to be approved so far,2 Contrave has not yet received a complete clearance from the regulatory authorities. The FDA has a list of postmarketing requirements for the company to fulfill, which will assess:
• Cardiovascular risk
• Safety and efficacy in the pediatric population
• Effect on growth and development in an animal model
• Effect on cardiac conduction
• Dosing in patients with hepatic or renal impairment
• Drug interactions.1
Approved for use in obese or overweight adults who have at least 1 weight-related condition (hypertension, type 2 diabetes mellitus, or dyslipidemia),1 the drug was rejected by the FDA back in 2011 due to concerns of cardiovascular safety on long-term use in the target population.2 Additionally, bupropion is an anti-depressant.
Contrave has a boxed warning on increased risk of suicidal thoughts and behaviors. Some of the other effects of Contrave, observed in clinical trials that evaluated 4500 obese and overweight patients, include seizures, hypertension, and increased heart rate. Other adverse reactions observed were nausea, vomiting, dizziness, constipation, headache, insomnia, dry mouth, and diarrhea.1References
1. FDA approves weight-management drug Contrave [press release]. Silver Spring, MD: FDA; September 10, 2014. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm413896.htm.
2. Nainggolan L. FDA approves bupropion/naltrexone (Contrave) for obesity. Medscape website. http://www.medscape.com/viewarticle/831513?src=wnl_edit_tpal&uac=217995HV. Published September 10, 2014. Accessed September 11, 2014.