When will it be available?
Achieving approval of this drug has not been easy. Vivus Inc., the company who will make Qnexa, submitted their application to the United States Food and Drug Administration (FDA) initially in 2009. This application was based on the results of a few published studies on weight loss, EQUIP and CONQUER. In January 2011, the FDA asked Vivus to further look at the possibility of birth defects in the drug before approval. The FDA also expressed concern about other possible side effects, including suicidal thoughts, heart palpitations, and memory lapses. On February 22, 2012, a subcommittee of the FDA voted 22 to 2 to approve the drug. On July 17, 2012, the full FDA is expected to follow the sub-committee recommendation and approve Qnexa. It will likely be 3 to 6 months after approval before it is available for use.
Qnexa, the first new weight-loss drug since 1999, is long overdue. It will be a good tool in the treatment of obesity. Combination drugs have been shown to improve compliance in taking all doses of a drug as prescribed. Although both phentermine and topiramate will remain available on their own in generic forms, Qnexa will be the strongest combination drug available to treat obesity and being overweight. Finally, it is important to remember that Qnexa is just one of many tools for weight loss. Its best effects will be seen as part of a complete program for weight loss that includes diet, exercise, behavior change, and adequate sleep.
Allison DB, Gadde KM, Garvey WT, et al. Controlled-release phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP).
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Gadde KM, Allison DB, Ryan DH, et al. Effects of low-dose, controlled- release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial. Lancet. 2011;377(9774):1341–1352. Epub 2011 Apr 8.
Garvey WT, Ryan DH, Look M, et al. Two-year sustained weight loss and metabolic benefits with controlled- release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo- controlled, phase 3 extension study. Am J Clin Nutr. 2012;95(2):297–308. Epub 2011 Dec 7.