In its CRL, the FDA has informed Vivus that the NDA for Qnexa cannot be approved in its present form.
The CRL included the following areas: clinical, labeling, REMS, safety update and drug scheduling.
In the clinical section of the CRL, the FDA requested a comprehensive assessment of topiramate’s and phentermine/topiramate’s teratogenic potential.
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.
As part of the written response, Vivus plans to compile analyses integrating existing nonclinical and clinical data to provide a comprehensive assessment of the teratogenic potential of topiramate.
In addition, Vivus also intends to provide several new analyses to demonstrate Qnexa does not increase the risk for major cardiovascular events, which would include data from our OB-305 and OB-204 studies.
Vivus CEO Leland Wilson said that they remain confident in the efficacy and safety profile of Qnexa demonstrated in the clinical development program and look forward to continue working with the FDA towards the approval for the treatment of obesity.
"We are preparing a comprehensive response to the CRL for submission to the FDA in approximately six weeks," Wilson said.