You are here

FDA Requests Additional Analyses and Supporting Information for Sumatriptan/Naproxen Sodium Agent

CHAPEL HILL, N.C.--(BUSINESS WIRE)--Dec. 13, 2006--POZEN Inc. (NASDAQ: POZN) announced today that the U.S. Food and Drug Administration (FDA) has completed its initial review of POZEN's response to the June 8, 2006 Approvable Letter for Trexima(TM) and has determined the response is not yet complete. The FDA has requested additional analyses and supporting information relating to the data submitted in the November response.

Provision of the additional information will allow the FDA to determine the comparability of the new data submitted in November to that contained within the original Trexima NDA and to more fully assess the relative safety profile of Trexima. POZEN expects to prepare and submit the revised response before year end.

Dr. Marshall Reese, executive vice president, product development of POZEN stated, "We appreciate this additional guidance from the FDA with respect to the information to be included in our complete response. Although there is no certainty that these revisions, coupled with the original data, will lead to the approval of the Trexima NDA, we continue to believe that the data for Trexima demonstrate superior efficacy and a safety profile comparable to sumatriptan."

Source: Pozen, Inc.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs