FDA Advisory Panel Votes to Approve Contrave Diet Pill
The US Food and Drug Administration’s Endocrine and Metabolic Drugs Advisory Committee has voted to approve Contrave, a sustained-release combination drug to help with weight loss. The medication has succeeded in passing FDA scrutiny while two others, Lorquess (lorcaserin hydrochloride) and Qnexa (phentermine/topiramate), did not receive the committee’s approval earlier this year.
Thirty-five Percent of Contrave Study Participants Lost at Least 5% of Body Weight
On Tuesday, the panel voted 13-7 for approval of Contrave, a combination of the antidepressant bupropion (brand name Wellbutrin) and naltrexone, used for narcotic addiction and alcoholism. The drug is manufactured by Orexigen Therapeutics based in LaJolla, California. In clinical studies, 35% of patients who took Contrave lost at least 5 percent of their body weight, 4.2% more than those who were taking a placebo.
The FDA will take the panel decision into consideration for ultimately approving the drug for sale in the United States. Likely, the decision will be made by the end of January 2011. While the agency isn’t required to follow advisory panel recommendations, it usually does.
Not everyone is happy with the panel decision. According to ABC News, Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group in Washington DC is leading a “major effort to stop this drug from being approved. He notes that 21 patients withdrew from the Contrave clinical trials because of increased blood pressure and heart rate and two were noted to have seizures during the study. The FDA is also reviewing the case of a fatal heart attack of one study subject whose blood pressure rose despite achieving significant weight loss.
Patient representative Melanie Coffin, who voted on the panel for approval of Contrave, said “It’s not going to be a perfect drug for everyone. But it will be useful for some.”
The FDA advisory panel did vote to recommend that if Contrave does become approved for sale, the manufacturer would be required to conduct additional cardiovascular studies of patients taking the drug.
The recommended daily dose of Contrave is two 8mg naltrexone/90 mg bupropion tablets taken twice daily (4 tablets total). Upon initiation, the drug will be started with a quarter-dose (or one tablet) for one week and a pill will be added to the regimen each week until the full recommended dose is reached on Week 4. This is similar to the escalation plan for other antidepressant medications.
If a patient hasn’t achieved meaningful weight loss (eg, at least 5%) after 4 months of treatment, the physician should consider discontinuation of Contrave and other strategies should be initiated.