By eigindia The US FDA has approved the weight-loss drug Qsymia, which now joins lorcaserin as the first anti-obesity medications to enter the US market since 1999. Qsymia, a controlled-release preparation of phentermine and topiramate in one capsule, is indicated for use in adults with a body mass index (BMI) of 30 or greater (obese), or those with a BMI of 27 or greater (overweight) who also have at least one weight-related comorbidity, such as hypertension, type 2 diabetes, or dyslipidemia.
Qsymia’s approval is based on data from two pivotal Phase III clinical trials, EQUIP and CONQUER, which demonstrated significant weight loss in patients using the drug in conjunction with lifestyle modifications. In these studies, patients who took the recommended dose of Qsymia lost an average of 8-10% of their body weight over one year, compared to those on a placebo.
Phentermine, a sympathomimetic amine, works as an appetite suppressant, while topiramate, an anticonvulsant, is believed to aid in weight loss by increasing satiety and reducing cravings. The combination of these two drugs in Qsymia allows for a synergistic effect, making it a powerful option for individuals struggling with obesity.
Despite its efficacy, Qsymia is not without risks. The FDA has placed it under a Risk Evaluation and Mitigation Strategy (REMS) program due to concerns about potential teratogenic effects, particularly birth defects if taken during pregnancy. Women of childbearing potential must take a pregnancy test before starting the medication and use effective contraception while on Qsymia. Other potential side effects include increased heart rate, mood changes, cognitive disturbances, and metabolic acidosis.
Healthcare professionals are advised to carefully assess the risks and benefits before prescribing Qsymia, ensuring that patients understand the importance of adherence to lifestyle changes for optimal results. The approval of Qsymia marks a significant step in the fight against obesity, providing patients with another tool to manage their weight effectively.
As the obesity epidemic continues to grow, the approval of new weight-loss medications like Qsymia and lorcaserin underscores the need for medical intervention in addition to diet and exercise. Researchers and healthcare providers remain hopeful that these drugs, along with future advancements, will help curb the rising obesity rates and improve public health outcomes.