The prevalence of obesity continues to be a health concern that affects a large and growing proportion of the population, including more than one third (more than 78 million) of American adults. Worldwide more than 500 million people are obese. Obesity directly contributes to numerous life-threatening conditions: diabetes, cardiovascular disease, hypertension and stroke and is the second leading cause of preventable death in the U.S.

Beyond its impact on health, it is estimated that obesity economically accounts for 9.1% of U.S. annual health care spending – nearly $150 billion dollars. By 2030, if trends in the escalating rates of obesity continue, health care costs attributable to obesity may reach $956 billion, accounting for up to 18% of total health care costs, or $1 in every $6 spent on health care.

The Product

Qnexa® (phentermine and topiramate) Extended-release Capsules is an investigational, once-per-day, weight-loss therapy that combines low doses of two agents approved by the Food and Drug Administration (FDA), phentermine and topiramate, in a controlled-release formulation.

Status

The company resubmitted the Qnexa NDA on October 17, 2011. On November 3, 2011, it was announced that the NDA was accepted for filing and review.  The FDA assigned a six-month, or class 2, review classification to the NDA, establishing April 17, 2012, as the Prescription Drug User Fee Act (PDUFA) target date.

The NDA resubmission seeks approval for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients, or overweight patients with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity). The proposed labeling includes a contraindication for women who are pregnant.

Clinical Studies

*In phase 2 and 3 clinical data to date, patients taking Qnexa have demonstrated statistically significant weight loss, glycemic control, and improvement in cardiovascular risk factors, when used in combination with a diet and lifestyle modification program. The most commonly reported side effects were tingling, dry mouth, constipation and altered taste.

REFERENCES:

Allison DB, Gadde KM, Garvey WT, Peterson CA, Schwiers ML, Najarian T, et al. Controlled-Release Phentermine/Topiramate in Severely Obese Adults: A Randomized Controlled Trial (EQUIP). Obesity (Silver Spring). Advance online publication 3 November 2011. doi:10.1038/oby.2011.330.

Gadde KM, Allison DB, 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. The Lancet, Volume 377, Issue 9774, Pages 1341 – 1352, 16 April 2011. doi:10.1016/S0140-6736(11)60205-5

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. AJCN. First published ahead of print December 7, 2011 as doi: 10.3945/ajcn.111.024927.

Retrieved from http://www.vivus.com/pipeline/qnexa-obesity.

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