Contrave
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| Combination of | |
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| Bupropion | Norepinephrine-dopamine reuptake inhibitor and nicotinic acetylcholine receptor antagonist |
| Naltrexone | Opioid receptor antagonist |
| Clinical data | |
| Trade names | Contrave |
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| Routes of administration |
Oral |
| ATC code | |
| Legal status | |
| Legal status |
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| PubChem CID | |
| KEGG | |
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Bupropion/naltrexone is a combination drug treatment for obesity. It combines bupropion and naltrexone. Both drugs have individually shown some evidence of effectiveness in weight loss, and the combination is expected to have a synergistic effect.
In September 2014, a sustained release formulation of the drug was approved for marketing in the United States under the brand name Contrave. The combination was subsequently approved in the European Union in the spring of 2015, where it will be sold under the name Mysimba.
Takeda recommends that Contrave should not be used in anyone who falls into any of the categories below:
The FDA has put a boxed warning onto this medicine because it may affect mood and increase the likelihood of suicide. Although rare, signs of mood and behavioral changes should be reported to a doctor.
Safety and effectiveness in children under the age of 18 has not been studied.
Individually, bupropion and naltrexone each target pathways in the central nervous system that influence food intake.
Combined, bupropion/naltrexone has an effect on the reward pathway that results in reduced food craving. In 2009, Monash University physiologist Michael Cowley was awarded one of Australia's top research honors, the Commonwealth Science Minister's Prize for Life Scientist of the Year, in recognition of his elucidation of these pathways, which led to the development of the combination medication.
Orexigen submitted a New Drug Application (NDA) for this drug combination to the FDA On 31 March 2010. Having paid a fee under the Prescription Drug User Fee Act, Orexigen was given a deadline for the FDA to approve or reject the drug of 31 January 2011. On 7 December 2010, an FDA Advisory Committee voted 13-7 for the approval of Contrave, and voted 11-8 for the conduct of a post-marketing cardiovascular outcomes study. Subsequently, on 2 February 2011, the FDA rejected the drug and it was decided that an extremely large-scale study of the long-term cardiovascular effects of Contrave would be needed, before approval could be considered. It was ultimately approved in the United States in the fall of 2014.
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