FDA Blocks Trexima Approval Again
Posted on: Friday, 3 August 2007, 12:20 CDT
The FDA has delayed approval of Pozen and GlaxoSmithKline's Trexima for a second time, requesting more information relating to a preclinical study assessing the combination migraine drug.
In January 2007, Pozen and GSK responded to the FDA's first approvable letter, submitting additional safety data from clinical trials, data from GSK's database, and additional in vitro preclinical data. In the second letter, the FDA has requested that Pozen further address the agency's concern about an in vitro study where genotoxicity was seen for the combination of naproxen sodium and sumatriptan, but not with either component alone.
None of the other three standard genotoxicity studies demonstrated any genotoxicity for the combination of naproxen sodium and sumatriptan, the companies said. Pozen and GSK said that they intend to request a meeting with the FDA as quickly as possible to discuss the necessary steps to address the agency's concerns.
Trexima contains GSK's migraine drug Imitrex with an NSAID, naproxen sodium, in a single tablet. Several new names are under consideration at FDA, but pending a final decision on a new name the product will still be referred to as Trexima.
Source: Datamonitor
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