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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. The
product is formulated with POZEN’s patented technology of combining
a triptan with a non-steroidal anti-inflammatory drug (NSAID) and
GlaxoSmithKline’s (GSK) RT Technology™. This migraine medication
works in two ways - the triptan component shrinks the swollen blood
vessels in the head, 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. As a result of this dual mechanism of action,
Treximet® has been shown to provide superior sustained pain
relief compared to placebo and to both of the single mechanism of
action components. The FDA approval was an important milestone for
the 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 May 2008, POZEN
officially transferred the Investigational New Drug (IND) and New
Drug Application (NDA) for the product to GSK. GSK is responsible
for the commercialization of Treximet® in the US. POZEN
receives royalties based on net sales of Treximet® from GSK
and, beginning January 1, 2010, that royalty rate will more than
triple to 18 percent.
POZEN also has ex-US rights to develop and market a lower dose
sumatriptan and naproxen combination.
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. |
