The US FDA today approved a new weight loss drug that will be called Qsymia,the brand name for the combination of two previously approved drugs, phentermine and extended-release topiramate. The drug is manufactured by Vivus, Inc.
In a press release, the FDA said Qsymia had been approved for use in obese adults (BMI of 30 or above) or in overweight adults (BMI of 27 or above) with at least one other weight-related condition such as hypertension, diabetes, or dyslipidemia.
The label recommends a daily dose of Qsymia containing 7.5 mg of phentermine and 46 mg of extended-release topiramate. The drug will also be available at the higher dose of 15 mg of phentermine and 92 mg of extended-release topiramate.
According to the FDA, in clinical trials, at one year, patients taking the recommended dose had an average weight loss of 6.7%, while patients taking the higher dose had an average weight loss of 8.9%, when compared to patients taking placebo. People taking the lower dose of Qsymia who do not lose 3% of their body weight after 12 weeks are unlikely to achieve a sustained weight loss on the same dose. These patients should either discontinue the drug or move to the higher dose. After 12 weeks on the higher dose, people who do not achieve a 5% weight loss should discontinue the drug.
The combination drug is contraindicated during pregnancy. Because of the high risk of oral clefts in fetuses exposed to topiramate, women should have a negative pregnancy test before starting Qsymia and every month while taking the drug, in addition to using contraception. The drug is also contraindicated in people with glaucoma or hyperthyroidism. Because the drug may increase heart rate, its use in people with recent unstable heart disease or stroke is not recommended. In addition, the FDA recommends that all patients taking Qsymia have their heart rate monitored regularly, in particular when starting the drug or increasing the dose.
FDA is requiring Vivus to implement a Risk Evaluation and Mitigation Strategy (REMS), consisting of a Medication Guide for patients and a plan to educate prescribers and patients to avoid the increased risk of birth defects associated with the drug. Pharmacies will need to obtain a special certification before dispensing Qsymia. The FDA is requiring the company to perform a long-term cardiovascular outcomes trial.
The drug had previously been known as Qnexa, but was forced to change the name by the FDA “because too many other drugs ended in the same letters and it would have caused confusion,” Vivus President Peter Tam told Bloomberg News.
The approval of Qsymia, along with the approval a few weeks ago of Arena’s lorcaserin (Belviq), are the first new weight loss drugs approved by the FDA since 1999.
Click here to read the FDA press release…