July 18, 2012
Qsymia: Third Weight-Loss Drug Approved BY FDA In Thirteen Years
Lawrence LeBlond for redOrbit.com - Your Universe Online
The second new weight-management drug in 13 years has been approved by US regulators for use in people who are obese or overweight and have certain medical conditions.
Qsymia has been approved for use in obese adults with a body mass index (BMI) of 30 or greater or for overweight adults with a BMI of 27 or greater who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
Despite an FDA approval, critics fear the side effects of using Qsymia could be dangerous, like speeding up heart rates and causing birth defects, and have urged for further testing before gaining government approval.
However, Janet Woodcock, MD, director of the FDA´s Center for Drug Evaluation and Research, said: “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 co-morbid condition.”
“Obesity threatens the overall well being of patients and is a major public health concern,” she added.
Qsymia is a combination of two drugs already approved by the FDA, phentermine and topiramate. Phentermine was produced 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.
The safety and efficacy of Qsymia were evaluated in two randomized, placebo-controlled trials of which included around 3,700 obese and overweight people with and without weight-related conditions.
“All patients received lifestyle modification that consisted of a reduced calorie diet and regular physical activity” for the duration of the year-long trials, the FDA said in its ruling.
Results from the trials showed that after one year of treatment with the recommended and highest daily dosages of Qsymia, patients lost an average of 6.7 percent and 8.9 percent body size, respectively, over the control group. Roughly 62 and 69 percent of the patients lost at least five percent of body weight with the recommended and highest dose of Qsymia, compared to 20 percent in the placebo group.
Study leaders determined that those who did not lose at least three percent of their body weight by the 12th week of the study likely would not achieve and sustain weight loss with continued treatment at that given dosage.
Therefore, the FDA said those on recommended dosages should be evaluated at 12 weeks to determine, based on the amount of weight loss, whether to discontinue Qsymia or increase to the highest dosage. If after another 12 weeks the patient does not lose at least five percent of body weight, then Qsymia should be discontinued.
The FDA warned that Qsymia must not be used in patients with glaucoma or hyperthyroidism. It also warns that people with recent (within the last six months) or unstable heart disease or stroke should not use the drug. Regular monitoring of heart rate is recommended for all patients on Qsymia.
The FDA approved Qsymia with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a Medication Guide advising patients about important safety information and elements to assure safe use that include prescriber training and pharmacy certification. REMS´ goal is to educate prescribers and patients about the increased dangers of birth defects associated with first trimester exposure to Qsymia, the need for pregnancy prevention, and the need to discontinue therapy if pregnancy occurs. Qsymia will only be dispensed through specially certified pharmacies.
The drug´s approval comes with strict requirements on the drug maker´s part. Vivus will be required to conduct 10 post-marketing studies, including a long-term cardiovascular outcomes trial to assess the effect of Qsymia on the risk for major adverse cardiac events such as heart attack and stroke.
The most common side effects of Qsymia are tingling of hands and feet, dizziness, altered taste sensation, insomnia, constipation, and dry mouth.
Jacob Warman, chief of endocrinology at The Brooklyn Hospital Center, said Qsymia could be the next big hit in the obesity wars.
“I think the FDA knows that the general population is hungry for a diet drug,” he told AFP in an interview, noting that Qsymia exceeds the bar for considering weight loss “significant,” or higher than five percent of body weight loss.