FDA Approves Another Weight-Loss Pill, Qsymia

After 1999, a second weight pill of biopharmaceutical company Vivus has won the approval of the Food and Drug Administration. The new drug Qsymia has an addition to a reduced calorie diet and exercise for chronic weight management.

The first weight loss pill to get the FDA certification was Arena Pharmaceutical's pill Belviq in late June.

The drug receives an approval for the use in adults with a body mass index(BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) or who have at least one weight related condition such as high blood pressure ( hypertension), Type II diabetes or high cholesterol ( dyslipidemia).

Qsymia is a combination of two FDA-approved drugs, phentermine and topiramate, in an extended-release formulation. Phentermine is indicated for short-term weight loss in overweight or obese adults who are exercising and eating a reduced calorie diet. Topiramate is indicated to treat certain types of seizures in people who have epilepsy and to prevent migraine headaches. 

"Obesity threatens the overall well being of patients and is a major public health concern," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weight-related comorbid condition."

The FDA had in April deferred its decision on the Qsymia New Drug Application that was resubmitted in October 2011, and set an action date of July 17.

The FDA though restricts this drug during pregnancy as its damaging effects on the fetus are high. If the fetus is exposed to topiramate, a component of Qsymia, in the first trimester of pregnancy has an increased risk of oral clefts. In addition, patients with glaucoma or hyperthyroidism, and unstable heart disease or stroke should not take the drug.

The safety and efficacy of Qsymia were evaluated in two randomized, placebo-controlled trials that included approximately 3,700 obese and overweight patients with and without significant weight-related conditions treated for one year. All patients received lifestyle modification that consisted of a reduced calorie diet and regular physical activity.

Results from the two trials show that after one year of treatment with the recommended and highest daily dose of Qsymia, patients had an average weight loss of 6.7 percent and 8.9 percent, respectively, over treatment with placebo. Approximately 62 percent and 69 percent of patients lost at least five percent of their body weight with the recommended dose and highest dose of Qsymia, respectively, compared with about 20 percent of patients treated with placebo. Patients who did not lose at least three percent of their body weight by week 12 of treatment with Qsymia were unlikely to achieve and sustain weight loss with continued treatment at this dose.

Therefore, response to therapy with the recommended daily dose of Qsymia should be evaluated by 12 weeks to determine, based on the amount of weight loss, whether to discontinue Qsymia or increase to the higher dose.  If after 12 weeks on the higher dose of Qsymia, a patient does not lose at least five percent of body weight, then Qsymia should be discontinued, as these patients are unlikely to achieve clinically meaningful weight loss with continued treatment.

Dr. Lee Kaplan, director of the Massachusetts General Hospital Weight Control Program, said that Qsymia was likely to help some obese patients in significant ways and others not at all.
"No one should assume that a majority of people are going to see sudden and dramatic changes" with Qsymia, he said. "But it will be tremendously beneficial for a subset of patients."

Qsymia will only be dispensed through specially certified pharmacies.