Qnexa has demonstrated significant weight loss, glycemic control, reduction in sleep apnea events, and improvement in cardiovascular risk factors.

The US Food and Drug Administration (FDA) has accepted for filing VIVUS Inc’s new drug application (NDA) for its investigational drug, Qnexa, for the treatment of obesity. In phase 2 and 3 clinical data to date, use of Qnexa has demonstrated significant weight loss, glycemic control, reduction in sleep apnea events, and improvement in cardiovascular risk factors.
 
"The FDA's acceptance of the Qnexa NDA marks an important milestone in the development of Qnexa as a treatment for patients who are obese or overweight with co-morbidities," stated Leland F. Wilson, CEO of VIVUS. "We believe that Qnexa, if approved, will play an important role in treating the millions of patients living with obesity and related diseases, and who are in need of safe and effective options."

The target date for the FDA to complete its review of the Qnexa NDA is October 28, 2010.
 

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