Pozen Hits Primary Endpoints in Second Phase III Trial for Trexima

Pozen has achieved statistical significance for all regulatory endpoints for Trexima in the second of two Phase III pivotal trials.

In the 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 and versus sumatriptan. With respect to pain relief and the associated symptoms of nausea, photophobia and phonophobia, Trexima was superior to placebo at two hours for all parameters.

Trexima is GlaxoSmithKline's (GSK) proposed brand name for the combination of sumatriptan formulated with RT Technology 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 new drug application (NDA). Based upon discussions at the pre-NDA meeting, Pozen believes that no additional preclinical or clinical trials are necessary for submission. The Trexima NDA submission is now scheduled for the third quarter of 2005.