Qsymia: New weight loss drug which FDA approved

Qsymia: New weight loss drug which FDA approved

The U.S. Food and Drug Administration today approved Qsymia (phentermine and topiramate extended release) as a supplement to a reduced calorie diet and exercise management of chronic weight.

The drug is approved for use in adults with a body mass index (BMI) of 30 or more (obese) or adults with a BMI of 27 or more (overweight) who have at least one weight-related conditions such as blood pressure (cholesterol, hypertension), type 2 diabetes, or high (dyslipidemia).

BMI, which measures body fat based on weight of an individual and height, is used to define obesity and overweight categories. According to the Centers for Disease Control and Prevention, more than a third of adults in the United States are obese.

"Obesity threatens the well-being of patients overall and is a major concern of public health," said Janet Woodcock, MD, director of the FDA 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 weight management in chronic Americans are obese or overweight and have at least one weight-related condition comorbidity. "

Qsymia is a combination of two FDA approved drugs, phentermine and topiramate in a sustained release formulation. Phentermine is indicated for weight loss in short-term in overweight and obese adults who exercise and a diet reduced in calories. Topiramate is indicated for treating certain types of seizures in people with epilepsy and to prevent migraine headaches.

Qsymia should not be used during pregnancy because it can cause harm to the fetus. The data show that the fetus exposed to topiramate, a component of Qsymia in the first trimester of pregnancy has an increased risk of oral clefts (cleft lip with or without cleft palate). Females of reproductive potential must not be pregnant at the time of starting treatment Qsymia or become pregnant while taking Qsymia. Females of reproductive potential must have a negative pregnancy test before starting Qsymia and every month while using the drug and must use effective contraception while taking Qsymia constantly.

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

The recommended daily dose of 7.5 milligrams Qsymia contains 46 mg of phentermine and topiramate extended release. Qsymia is also available at a higher dose (15 mg 92 mg phentermine and topiramate extended release) for some patients.

The results of both tests show that after one year of treatment with the recommended dose and the highest daily Qsymia, patients had a mean weight loss of 6.7 percent and 8.9 percent, respectively, compared to treatment with placebo. About 62 percent and 69 percent of patients lost at least five percent of their body weight at the recommended dose and the highest dose of Qsymia, respectively, compared to about 20 percent of patients treated with placebo.

Patients who have not lost at least three percent of their body weight by 12 weeks of treatment with Qsymia were unlikely to achieve and maintain weight loss with continued treatment at this dose. Therefore, the response to treatment with the recommended daily dose of Qsymia should be evaluated by 12 weeks to determine, based on the amount of weight loss, whether to terminate or Qsymia increase the higher dose. If after 12 weeks on higher dosage 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 reach a clinically significant weight loss with continued treatment.

Qsymia should not be used in patients with glaucoma or hyperthyroidism. Qsymia can increase heart rate, effect of this drug on heart rate in patients at high risk of heart attack or stroke is not known. Therefore, the use of Qsymia in patients with recent heart disease (during the last six months) or unstable or stroke is not recommended. Regular monitoring of heart rate is recommended for all patients taking Qsymia, especially when starting or increasing the dose Qsymia.

The FDA approved Qsymia with a risk assessment and mitigation strategy (REMS), which consists of a Medication Guide to advise patients about important safety information and elements to ensure safe operation, including training prescriber and pharmacy certification. The goal of REMS is to educate prescribers and patients about the increased risk of birth defects associated with exposure of the first quarter of Qsymia, the need for pregnancy prevention, and the need to discontinue treatment if pregnancy occurs. Qsymia will be distributed in pharmacies specially certified.

Vivus Inc. will be necessary to carry out 10 requirements for pharmacovigilance, including long-term cardiovascular outcomes trial to evaluate the effect of Qsymia the risk for major adverse cardiac events such as heart attack and stroke.

The most common side effects are tingling in Qsymia hands and feet (paresthesia), dizziness, altered taste, insomnia, constipation, and dry mouth.

Qsymia is marketed by Vivus Inc. in Mountain View, California

The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of medicinal products for human and veterinary vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety and security of food supply in our country, cosmetics, food supplements, products that emit electronic radiation, and to regulate tobacco products.