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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. |
