Treximet
sumatriptan succinate and naproxen sodium
Treatment for MigrainePOZEN 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.
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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
Pozen Inc. and GlaxoSmithKline Report Receipt of Approvable Letter for Investigational Migraine Treatment - June 9, 2006
GlaxoSmithKline and POZEN Announce Trexima (Sumatriptan Succinate and Naproxen Sodium) New Drug Application Accepted for Review by FDA - October 11, 2005
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