FDA accepts new drug application filing for Qnexa

The resubmission seeks approval for Qnexa to treat obesity, including weight loss and maintenance of weight loss for obese patients (BMI > 30 kg/m2). It is also intended for use for overweight patients (BMI > 27 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or abdominal obesity.

Qnexa is being developed to address weight loss, type 2 diabetes and obstructive sleep apnea. Qnexa is a once-a-day, oral, controlled-release formulation of low-dose phentermine and topiramate. It is designed to decrease one's appetite and increase the feeling of being full and satisfied - the two main contributing factors to eating behaviour. In phase 2 and 3 clinical data to date, patients taking Qnexa have demonstrated statistically significant weight loss, glycemic control, and improvement in cardiovascular risk factors, when used in combination with a diet and lifestyle modification program. The most commonly reported side effects were tingling, dry mouth, constipation and altered taste.