Vivus submits briefing document to US FDA on obesity drug candidate Qnexa

California, USA-based Vivus (Nasdaq: VVUS), as part of its continuing effort to secure regulatory approval for its obesity drug candidate Qnexa (phentermine/topiramate) the USS, submitted a briefing document to the Food and Drug Administration designed to address items in the FDA's Complete Response Letter (CRL), issued on October 28, that followed an earlier negative opinion from an advisory panel (The Pharma Letter July 16).

The company also announced that the Endocrine and Metabolic Division of the FDA has granted VIVUS a meeting in the second half of January 2011 to discuss the content of the proposed resubmission.

"Submission of our briefing document and confirmation of our meeting with the FDA indicate the continued progress Vivus is making in seeking US approval of Qnexa for the treatment of obesity," said Leland Wilson, chief executive of the firm. "We are confident in the data analyses we have compiled in the briefing document, and we look forward to our meeting with the FDA,” he added.