Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.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.
Subscribe to our email newsletter
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.