ParagonRx® | Minimize Risk and Optimize Use

VIVUS, Inc. today announced that following recent discussions with Food and Drug Administration (FDA) officials, the company has been asked to remove the Qnexa® contraindication for women of childbearing potential contained in the proposed label.  Qnexa would remain contraindicated for women who are pregnant.  A contraindication typically indicates that a drug should not be used because the risk of use clearly outweighs any possible therapeutic benefit.

Included with the resubmission of the Qnexa New Drug Application (NDA) was a proposed Risk Evaluation and Mitigation Strategy, or REMS.  The company is currently revising its proposed REMS based on this change in the contraindication and plans to discuss the details of the Qnexa REMS during the upcoming Endocrinologic and Metabolic Drugs Advisory Committee.

"Based on our discussions with the FDA, we will modify the contraindication and develop an appropriate REMS with FDA's guidance.  It is important for patients seeking treatment to understand and be reminded of the potential risks associated with Qnexa.  In addition to other elements, the proposed REMS program will focus on the education of patients and healthcare providers through frequent communications that will outline the safety aspects and appropriate use of Qnexa," commented Peter Tam, president of VIVUS, Inc.

"The company's disclosure of this regulatory update should not be interpreted to mean that the potential for FDA approval of Qnexa has improved or that, if approved, that the final Qnexa label would not include contraindications or warnings for specific populations, including women of childbearing potential."

In September 2011, the company announced that it reached agreement with the FDA on a plan that allowed for an early resubmission of the Qnexa NDA.  The resubmission plan allowed VIVUS to seek approval for an initial indication that included obese men and women of non-childbearing potential which contained a contraindication for women of childbearing potential. Based on this agreement, VIVUS resubmitted the Qnexa NDA in October 2011.  The FDA accepted the NDA for review on November 3, 2011.

The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA is scheduled to review the Qnexa NDA on February 22, 2012.  The target date for the FDA to complete its review of the Qnexa NDA is April 17, 2012.

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