VIVUS has reached agreement with officials of the Endocrine and Metabolic Division of the FDA on a plan that allows for an early resubmission of the QNEXA New Drug Application for the treatment of obesity. The resubmission plan allows VIVUS to seek approval for an initial indication that includes obese men and women of non-child bearing potential. Based on this agreement, VIVUS intends to resubmit the QNEXA NDA by the end of October 2011, prior to completion of the FORTRESS study.
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.
"Recent epidemiology study results, which show that topiramate is not a major teratogen, were an important consideration in our plan to resubmit the QNEXA NDA ahead of the FORTRESS results. The planned October resubmission will also allow for an early 2012 Advisory Committee meeting and a second quarter 2012 PDUFA date," commented Peter Y. Tam, president of VIVUS.
"In this initial indication, we plan to include a contraindication for women of childbearing potential. We believe this is a sound approach that, if approved, will potentially allow early commercialization in a higher-risk population with a significant unmet medical need. The FORTRESS study remains important in our plan to more precisely define the teratogenic potential of topiramate and may enable us to expand the indication to include obese women of child-bearing potential. If the FORTRESS results are favorable, we expect to file for the full indication in late 2012,” said Tam.