The FDA rejected the drug's application last year because it was not more effective than existing treatments.
They are mixing Trexima up with Pozn's other migraine drug. Trexima hasn't yet been submitted to the FDA.
I hold a fair amount of POZN, so this is good news, particularly the fact that they have had a meeting with the FDA. Looks like the FDA must have retreated from their ridiculous stance that the sole measure of a migraine drug's effectiveness is pain and nausea relief at 2 hours. For a combination drug, you have to show it's better than each component:
POZEN Hits All Primary Endpoints in Second Phase III Pivotal Trial for Trexima; NDA Submission Scheduled for 3Q 2005
CHAPEL HILL, N.C.--(BUSINESS WIRE)--April 21, 2005--POZEN Inc. (NASDAQ: POZN), announced today that it achieved statistical significance for all regulatory endpoints for Trexima in the second of the two Phase III pivotal trials. Trexima(TM) is GlaxoSmithKline's (GSK) proposed brand name for the combination of sumatriptan formulated with RT Technology(TM) and naproxen sodium in a single tablet. GSK and POZEN are collaborating on the development of Trexima.
POZEN also announced that it has met with the FDA and discussed the results of both Phase III trials and other information required for the submission of the Trexima NDA. Based upon discussions at the pre-NDA meeting, POZEN believes that no additional pre-clinical or clinical trials are necessary for submission. The Trexima NDA submission is now scheduled for the third quarter of 2005.
In the second Phase III study, Trexima demonstrated superiority over the individual components on the primary endpoint and also met all the regulatory endpoints for a new migraine product. For the combination, Trexima demonstrated a superior sustained pain-free response versus naproxen (p<0.001) and versus sumatriptan (p=0.009). With respect to pain relief and the associated symptoms of nausea, photophobia, and phonophobia, Trexima was superior to placebo at 2 hours for all parameters (p=0.007 for nausea, p<0.001 for the others).
"We are obviously very pleased with the pre-NDA meeting resulting in our ability to submit the Trexima NDA early in the second half of this year," said Dr. John R. Plachetka, Chairman, President and CEO. "The team has done a remarkable job in completing the two pivotal studies in less than a year from start to finish." |
