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FDA Approves Vivus’ Obesity Medication Qsymia

On July 17, the FDA approved Vivus’ weight-loss medication Qsymia (formerly called Qnexa), just several weeks after the approval of Arena’s Belviq (see new now next in diaTribe #44). Qsymia is a once daily pill intended for use with diet and exercise by obese adults (body mass index [BMI] of 30 kg/m2 or greater) or overweight adults (BMI of 27 kg/m2 or greater) with at least one weight-related condition (e.g., diabetes, high blood pressure, high cholesterol). Qsymia should be available in late 2012, though initially only through certified mail-order pharmacies. Vivus has not yet disclosed how much Qsymia will cost; regardless, most people who take the drug will likely need to pay for it out of pocket when it’s launched. Insurance coverage for obesity medications has historically been limited, though Vivus is optimistic it will obtain coverage within a year of launching Qsymia because the drug has been shown to reduce weight-related health problems.

In clinical trials, Qsymia treatment brought about an average ~10% weight loss over two years, compared to ~2% weight loss with placebo. The most common side effects include paresthesia (“pins and needles”), dry mouth, and constipation. The label for Qsymia recommends starting at a low dose and slowly increasing the dose over time, presumably to minimize side effects and to help patients tolerate the drug. Importantly, the drug’s label includes stopping rules (instructions to discontinue if a pre-specified amount of weight loss is not achieved by a certain time) to ensure that patients who are not responsive to the therapy are not needlessly exposed to its potential risks.

As background, in October 2010, the FDA chose not to approve the drug due in large part to the potential birth defect risk of topiramate, a component of the drug. Though in subsequent studies the drug had a lower birth defect rate than initially believed, infants exposed to the drug in the first trimester of pregnancy were found to be at higher risk for developing oral clefts. In this more recent approval cycle, Vivus developed a plan (called a Risk Evaluation and Mitigation Strategy or “REMS”) to minimize the use of Qsymia by pregnant women and thereby mitigate the risk of birth defects. The REMS for Qsymia includes educational materials for patients and healthcare professionals on the risk of birth defects, the importance of contraception and regular pregnancy testing for women using Qsymia, and the need to stop taking Qsymia immediately if and when one gets pregnant. The FDA’s approval of Qsymia reflects the Agency’s high level of comfort that the REMS can effectively minimize use of the drug by pregnant women.

After so long without any new medications for the treatment of obesity, two new options will become available in the not-too-distant future – Qsymia and Belviq. Encouragingly, obesity is becoming increasingly recognized as a chronic disease with significant health consequences if left unaddressed, as opposed to a cosmetic condition resulting from lack of willpower and self-control – or even worse, a personal choice. In the coming months and years, we hope to see additional obesity treatments – lifestyle interventions, drugs, devices, online counseling, and combinations of all of them – become available, as well as additional efforts to prevent obesity from developing in the first place. –JD/VW

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