From Pharmacy Drug Guide
Contrave®, an experimental weight loss drug, was denied FDA approval on January 31, 2011 pending a randomized study "of sufficient size and duration" to demonstrate that the cardiovascular risks of Contrave® do not exceed the obesity medication's benefits. The drug's manufacturer, Orexigen Therapeutics, is working toward a new approval date of 2014. According to Orexigen, Contrave® addresses both physiological and behavioral drivers of obesity. Previous clinical trial results had shown that participants taking Contrave® for more than a year lost an average of 6.1 percent body fat. Trial participants began losing weight four weeks after beginning Contrave® and maintained their weight loss throughout the 56 weeks of the study.
Flickr: Alan Cleaver
|Brand name for||Combination of naltrexone and buproprion|
|Manufacturer||Orexigen Therapeutics, Inc.|
|Phone number||(858) 875-8600|
|Uses||Treatment of obesity|
|FDA Advisory Committee Meeting||December 7, 2010|
|Disclaimer||The information provided by PharmacyDrugGuide.com is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician.|
Contrave® is not a new drug, but a sustained release formulation of bupropion, an antidepressant, and naltrexone, used in the treatment of drug addiction and alcoholism. According to Orexigen Therapeutics, Contrave® reduces appetite and food cravings, increases metabolism and maintains continued weight loss by reducing incidents of metabolic syndrome.
Orexigen Therapeutics, the company that manufactures Contrave®, maintains that it has been designed to work on the biological systems that control mood and appetite. Researchers believe the main reason for its clinical trial effectiveness is the use of buproprion and naltrexone in targeting different areas involved in weight loss.
Naltrexone has been used to treat opioid addiction since 1984. In 1995, it was used to treat alcoholism as well. Naltrexone blocks opioid receptors to the brain and inhibits the reinforcement of addictive substances. It has also been shown to alter the taste of food.
Bupropion has been used to treat depression since 1985. In 1997, trials experimented with its use in the process of assisting smokers to stop smoking cigarettes. Bupropion also appears to be an effective appetite suppressant, and in increasing energy levels. A noted side effect of bupropion is weight loss.
Contrave Side Effects
Some of the potential side effects reported during the Contrave® clinical trials are:
- mild to moderate nausea
Contrave FDA Approval Process
- March 31, 2010: Orexigen Therapeutics submits a New Drug Application (NDA), seeking approval to market Contrave® in the United States
- June 1, 2010: FDA accepted the NDA
- December 7, 2010: FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13-7 to recommend approval of Contrave®. The FDA is expected to make a decision by January 31, 2011.
- January 31, 2010: FDA denied Contrave® approval, noting concerns about the cardiovascular safety profile of naltrexone/bupropion when used long-term in a population of overweight and obese subjects. Orexigen anticipates meeting with FDA representatives to discuss the future of the weight loss medication.
- June 3, 2011: Orexigen Therapeutics issued a statement declaring that they had recently convened with the FDA to further clarify the steps required to facilitate Contrave® approval. Orexigen claimed that they were not satisfied with the double-blind, placebo study requirements previously set forth, stating that the sort of research described by the FDA was excessive. They proposed their own solution, which was rejected by the Division of Metabolic and Endocrinologic Products (DMEP).
- September 20, 2011: Orexigen announced that they had met with senior officials in FDA's Office of New Drugs (OND) and had received a letter detailing OND's design requirements for a new cardiovascular safety trial. Orexigen finds these requirements "reasonable and feasible" and believes that Contrave® could potentially be approved in 2014.
Contrave FDA Advisory Committee Meeting
The Endocrinologic and Metabolic Drugs Advisory Committee met to discuss "the safety and efficacy of new drug application (NDA) 20-0063, proposed tradename CONTRAVE® (naltrexone HCl/bupropion HCl) extended-release tablets, for the treatment of obesity and weight management, including weight loss and maintenance of weight loss in patients with an initial body mass index (BMI) of equal to or greater than 30 kilograms (kg) per square meter, or a BMI equal to or greater than 27 kg per square meter with one or more risk factors (e.g. diabetes, dyslipidemia, or hypertension) on December 7, 2010.
On June 3, 2011, Contrave® manufacturer Orexigen stated that they had met with FDA representatives to discuss the research necessary for the drug's approval. The company proposed a study that was deemed insufficient by the Division of Metabolic and Endocrinologic Products (DMEP), who suggested an alternative study. Orexigen was not satisfied with the suggestion, claiming that the it would be overly complicated and require the collection of more data than is necessary.
In September 2011, Orexigen officials met with senior officials in FDA's Office of New Drugs to discuss design requirements for a cardiovascular outcomes trial (CVOT). Orexigen believes the result of this meeting was a "very clear and feasible path forward" toward possible approval for Contrave® in 2014.
Contrave Clinical Trials