VIVUS, Inc. (VVUS) Shares Jump 26%

VIVUS, Inc. (NASDAQ:VVUS) shares jumped 26.43% to $7.75 on Friday after the company announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for the investigational new drug QNEXA® (phentermine/topiramate) Controlled-Release Capsules. The FDA decided that the NDA cannot be approved in its present form. The application seeks the approval to market QNEXA as an oral, once-a-day formulation for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity. FDA requested a comprehensive assessment of topiramate’s and phentermine/topiramate’s teratogenic potential asking asked VIVUS to provide evidence that the elevation in heart rate associated with phentermine/topiramate does not increase the risk for major adverse cardiovascular events. The FDA requested that VIVUS formally submit the results from the already completed SEQUEL study (OB-305), a 52-week extension study for a subset of 675 patients who completed the previously reported 56-week CONQUER study. Top-line results from the two-year SEQUEL study were announced by VIVUS on September 21, 2010 and a final study report is being prepared for submission to the NDA. Finally, the FDA stated that if approved, phentermine/topiramate would be a Schedule IV drug due to the phentermine component. Leland Wilson, chief executive officer of VIVUS stated that the company remains confident in the efficacy and safety profile of QNEXA demonstrated in the clinical development program and looks forward to continue working with the FDA towards the approval for the treatment of obesity. VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company’s lead product in clinical development is QNEXA®, which also is in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction.
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