New Drug Applications

Treximet

sumatriptan succinate and naproxen sodium

Treatment for Migraine

Update: Treximet Now FDA Approved - April 15, 2008

POZEN Submits New Drug Application for Trexima (Sumatriptan Succinate and Naproxen Sodium) for the Acute Treatment of Migraine

CHAPEL HILL, N.C., August 8, 2005 - POZEN Inc. (NASDAQ: POZN) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of Trexima, the proposed brand name for the combination of sumatriptan succinate, formulated with RT Technology (TM), and naproxen sodium, in a single tablet for the acute treatment of migraine.

Dr. Marshall Reese, executive vice president, product development stated, "We are pleased to submit the Trexima NDA ahead of schedule and within four months from the database lock on the last pivotal clinical study for the NDA. This has been a well-executed development program with good collaborative efforts put forth by team members from both GlaxoSmithKline (GSK) and POZEN."

About Migraine

Migraine affects more than 28 million people in the Unites States alone, of which roughly three out of four migraine sufferers are women. According to the International Headache Society's diagnostic criteria, migraine is characterized by recurrent headaches lasting 4 to 72 hours (untreated) and with symptoms including moderate to severe headache pain, throbbing head pain, head pain located on one side of the head, head pain aggravated by routine activity, nausea, vomiting, and sensitivity to light and sound. Migraine can be disabling and sufferers may miss days of work, lose time with family and friends, and be unable to pursue basic daily activities.

Source: POZEN Inc.

Related Articles:

Treximet (sumatriptan and naproxen sodium) Tablets Approved by FDA for Acute Treatment of Migraine - April 16, 2008

Pozen Submits Human Lymphocyte Study for Treximet (Formerly Known as Trexima) - January 16, 2008

Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA - November 1, 2007

Pozen Submits Response to Approvable Letter for Trexima - October 15, 2007

Pozen Plans to Submit Response to Approvable Letter For Trexima Within the Next Ten Days - October 5, 2007

FDA Issues Second Approvable Letter for Trexima - August 2, 2007

Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA - March 22, 2007

Pozen Expects to Submit Revised Response to Trexima Approvable Letter by Year End - December 13, 2006

Pozen Submits Full Response to FDA Approvable Letter For Trexima - November 9, 2006

Pozen to Submit Full Response to Trexima Approvable Letter During the Fourth Quarter - July 31, 2006