No FDA Nod for Vivus, Inc. (NASDAQ: VVUS)
July 16th, 2010 at 12:41 pm Posted by
If you’re not hiding out in a hole like an ostrich with its head stuck in the sand, you’d know that shares of Vivus, Inc. (NASDAQ: VVUS) have plummeted nearly 60% this morning.
VVUS, a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health, closed at $12.11 Thursday, July 15, 2010. After market close, however, the company issued a press release discussing reasoning behind the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voting against the company’s Qnexa “for the treatment of obesity in individuals with a body mass index (BMI) greater than or equal to 30 kg/m2 or 27kg/m2 with weight-related co-morbidities,” including hypertension, diabetes and dyslipidemia.
Qnexa, an investigational, once a day, oral formulation of low does phentermine and topiramate, “which is believed to address both appetite and satiety – the two main mechanisms that impact eating behavior,” is the company’s lead product in clinical development.
The drug candidate has completed Phase 3 clinical trials for the treatment of obesity, and an New Drug Application (NDA) has been filed, and accepted by, the FDA, “with an acceptance date of October 28, 2010.”
Additionally, Qnexa is in Phase 2 clinical development for the treatment of Type II diabetes and sleep apnea.
Currently, VVUS shares are down 58.13% at $5.07.
