FDA accepts new drug application filing for Qnexa

Vivus has announced that the Food and Drug Administration (FDA) has accepted, for filing and review, the new drug application for Qnexa. Qnexa is a prescription diet pill which has been denied FDA approval in the past. Vivus resubmitted the new application mid-October 2011.

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.