New Drug Applications

Treximet

sumatriptan succinate and naproxen sodium

Treatment for Migraine

Update: Treximet Now FDA Approved - April 15, 2008

Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA

CHAPEL HILL, N.C., March 22, 2007 -- Pozen Inc. today announced the amended response to a previous FDA approvable letter for Trexima has been accepted for review by the U.S. Food and Drug Administration (FDA). Trexima is the proposed brand name for the combination of sumatriptan succinate, formulated with RT Technology, and naproxen sodium, in a single tablet for the acute treatment of migraine. The FDA has also notified Pozen that it expects a Class II review (six months), which could result in a new decision date of August 1, 2007. Pending FDA approval, the product could be available to patients in the second half of 2007.

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, which is typically throbbing, unilateral, and aggravated by routine activity, nausea, vomiting, and sensitivity to light and sound. Migraine can be disabling and sufferers may miss work, lose time with family and friends, and be unable to pursue basic daily activities.

About Imitrex (sumatriptan succinate) Tablets

Imitrex is a prescription medication indicated for the acute treatment of migraine in adults. Imitrex should only be used when a clear diagnosis of migraine has been established. Patients should not take Imitrex if they have certain types of heart disease, history of stroke or TIAs, peripheral vascular disease, Raynaud syndrome, or blood pressure that is uncontrolled. Patients with risk factors for heart disease, such as high blood pressure, high cholesterol, diabetes or are a smoker, should be evaluated by a doctor before taking Imitrex. Very rarely, certain people, even some without heart disease, have had serious heart related problems. Patients who are pregnant, nursing, or taking medications should talk to their doctor.

About Naproxen Sodium

Naproxen sodium is a non-steroidal anti-inflammatory drug (NSAID) and is contained in Anaprox, Anaprox DS, Naprelan, Aleve and in a number of over-the-counter medications. Naproxen sodium is indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and juvenile arthritis. It is also indicated for the treatment of tendinitis, bursitis, acute gout and for the management of pain and primary dysmenorrhea. Naproxen-containing products should not be used by patients who have had allergic reactions to any product containing naproxen, nor in patients in whom aspirin or other NSAIDs induce the syndrome of asthma, rhinitis, and nasal polyps. Patients who have a history of peptic ulcer or gastrointestinal bleeding, kidney problems, uncontrolled hypertension or heart failure should consult a physician before using naproxen-containing medications. NSAIDs may cause increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke. This risk may increase with duration of use and in patients with cardiovascular disease or risk factors for cardiovascular disease. Serious gastrointestinal toxicity such as bleeding, ulceration and perforation can occur at any time in patients treated chronically with NSAID therapy and physicians should remain alert for such effects even in the absence of previous GI tract symptoms. Patients who are pregnant or are nursing should consult a physician before use of a naproxen-containing medication.

Source: Pozen

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 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