Orexigen Therapeutics (OREX), maker of the weightloss drug candidate Contrave, are awaiting FDA approval for the third newest diet pill likely to be approved. Contrave is the third prescription diet drug candidate to face the FDA’s advisory panel this year, and after Vivus’s (VVUS) Qnexa and Arena Pharmaceuticals’s (ARNA) Lorcaserin had their FDA decision delayed due to safety concerns.
Currently the company is conducting clinical trials for its diet pill Contrave and will submit its results to the FDA to counter health and side effect concerns raised by the FDA.
Contrave®
Background
Contrave (naltrexone SR/bupropion SR) is an investigational medication for the treatment of obesity. With its unique mechanism of action in the CNS, Contrave has the potential to change the way obesity is treated by:
- Initiating weight loss by reducing appetite and increasing metabolism
- Allowing the body to sustain continued weight loss by offsetting its natural tendency to fight back and slow down the weight loss process
- Addressing the reward system in the brain that causes food cravings
Contrave is a combination of two well-established drugs, naltrexone and bupropion, in a sustained release formulation (SR).
- The active ingredients of Contrave have been used for over 20 years.
- Bupropion is a widely-prescribed antidepressant and smoking cessation medication; naltrexone is a treatment for alcohol and opioid addiction.
- We believe that bupropion helps initiate weight loss while naltrexone may sustain weight loss by preventing the body’s natural tendency to counteract efforts to lose weight.
Contrave® Scientific Rationale
Contrave is a fixed-dose combination of naltrexone sustained-release (SR) and bupropion SR. Orexigen developed its own proprietary SR version of naltrexone in an effort to improve drug tolerability. Bupropion acts on the weight control circuit by stimulating the POMC neuron. Naltrexone prevents inhibition of POMC neurons by blocking the action of β-endorphin.