VIVUS’ Qsymia Receives the US FDA’s Approval for the Treatment of Obesity in Adolescents Aged 12-17 Years
Shots:
- The US FDA has approved Qsymia (phentermine and topiramate extended-release capsules) CIV for obesity in adolescents aged 12-17yrs.
- The approval was based on the P-III trial of Qsymia in adolescent patients with obesity which showed a significant reduction in BMI, 44% of patients in the top-dose Qsymia group lost at least 15% of their body weight & ~30% lost at least 20% of their body weight, the incidence of patients reporting 1 AEs was 51.8%, 37.0% & 52.2% in the PBO, mid and top-dose Qsymia groups, respectively
- Qsymia was approved for use as an addition to a low-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of >30 kg/m2 (obesity) or 27 kg/m2 (overweight)
Ref: Globe Newswire | Image: Vivus
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