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TREXIMET


In April 2008, the Food and Drug Administration (FDA) approved Treximet™ (sumatriptan and naproxen sodium) for the acute treatment of migraine attacks, with or without aura, in adults.  Formulated with POZEN’s patented technology of combining a triptan with a non-steroidal anti-inflammatory drug (NSAID) and GlaxoSmithKline’s (GSK) innovative RT Technology™, the approval was the culmination of a successful partnership between the two companies. The partnership began in 2003, when GSK signed an agreement with POZEN for the development and commercialization of this product.

In response to this need for a migraine-specific therapy that targets both neurovascular and inflammatory events, POZEN and GSK co-developed Treximet. This migraine medication works in two ways - the triptan component alters the constriction of the blood vessels, which correlates to the relief of migraine pain, while the NSAID component inhibits the enzyme responsible for the production of prostaglandins, which are the mediators of pain and inflammation, thereby enhancing the speed, effectiveness and duration of migraine symptom relief.

Treximet contains 85 mg sumatriptan, formulated with GSK’s RT Technology™, and 500 mg naproxen sodium. In clinical trials, Treximet provided a significantly greater percentage of patients migraine pain relief at two hours compared to placebo for pain relief, nausea, photophobia and phonophobia. In addition, Treximet provided more patients sustained migraine pain free from two to 24 hours compared to sumatriptan and naproxen sodium.

In May 2008, POZEN officially transferred the IND and NDA for the product to GSK.  GSK is responsible for commercialization of Treximet.  POZEN will receive royalties based on net sales from GSK.

Full prescribing information is available on www.Treximet.com.

About Migraine Headaches

Migraine headaches are a significant problem and affect an estimated 29.5 million Americans, nearly half of which are undiagnosed. According to the International Headache Society's diagnostic criteria, migraine is characterized by recurrent headaches which, if untreated, typically last four to 72 hours, 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.

Of those diagnosed with migraines, 10 million patients receive a prescription; however only four million receive migraine-specific medications.  Recent data show that many of these patients are often prescribed narcotics and opioid analgesics, which are not approved for migraine treatment, instead of triptans, which are migraine-specific medications. This is unfortunate because the use of narcotics and opioid analgesics can lead to loss of productivity, a greater risk of Medication Overuse Headaches (also known as chronic daily headache or rebound headaches), and potentially result in abuse and dependency.