VIVUS, Inc. 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 an obesity drug, QNEXA.
The company announced today that, following a recent teleconference, it has reached agreement with officials of the Endocrine and Metabolic Division of the Food and Drug Administration (FDA) on a plan that allows for an early resubmission of the QNEXA New Drug Application for the treatment of obesity. Based on the agreement, VIVUS intends to resubmit it by the end of next month.
This date will be prior to the completion of the FORTRESS study on the drug’s effect on obese men and women. Top-line results from FORTRESS are expected in December 2011, with validation of FORTRESS expected in the third quarter of 2012. The FDA also stated that an advisory committee meeting for QNEXA will be held in the first quarter of 2012.
The outcome of the study and the FDA meeting will be of great importance to VIVUS. The company is hoping QNEXA will help it break into the large global obesity market. In the United States alone, it is estimated there are over 108 million adult Americans who are either obese or overweight with at least one weight-related health risk such as diabetes and hypertension.
For further information on VIVUS and its QNEXA drug, please visit its website at www.vivus.com
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