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Data Show Significantly More Patients Were Pain-Free with Treximet(TM) (sumatriptan and naproxen sodium) Tablets in the Acute Treatment of Probable Migraine Without Aura in Adults

Saturday, June 28, 2008 General News
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BOSTON, June 27 Patients suffering from probablemigraine, which is defined as a sub-type of migraine that meets all but one ofthe migraine diagnostic criteria, frequently have difficulty finding effectivetreatment. To date, no available migraine-specific medications have proveneffective in treating this migraine sub-type. However, according to new data,Treximet is the first migraine-specific medication to demonstrate pain-freeresults in patients with probable migraine without aura. These data werepresented today at the 50th Annual Scientific Meeting of the American HeadacheSociety in Boston.
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Typically, this migraine sub-population experiences pain symptoms whichmay include pain on one side of the head, moderate to severe pain, throbbingpain or worse pain when moving or bending, but do not present with anassociated symptom, such as nausea or vomiting or sensitivity to light andsound.
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"The study findings are promising, as helping patients with this conditionfind adequate pain relief is often challenging," stated Stephen Silberstein,MD, professor of neurology and director of the Jefferson Headache Center atThomas Jefferson University, and a lead author of the study. "Treximet wassuperior to placebo in producing pain-freedom at two hours and sustainedpain-freedom from two through 24 hours."

Recently approved for the acute treatment of migraine attacks with orwithout aura in adults, Treximet is the first and only migraine productdesigned to target multiple mechanisms of migraine by combining a triptan andan anti-inflammatory pain reliever in a single tablet. The recommended dosagefor patients prescribed Treximet is one tablet and should only be used where aclear diagnosis of migraine has been established. Treximet is not indicatedfor the treatment of probable migraine.

About the Study

The randomized, placebo-controlled, parallel group, single attack,multi-center study evaluated 679 men and women who have a history of probablemigraine of at least six months and moderate to severe pain lasting at leastfour to 72 hours. Subjects were randomized to Treximet or placebo, and wereallowed to take a second dose of Treximet or their usual medication at twohours following initial treatment. Co-primary endpoints were pain-free at twohours and sustained pain-free from two through 24 hours.

Treximet was superior to placebo in producing pain-freedom at two hourspost-dose and sustained pain-free results from two through 24 hours:

-- Nearly one-third of subjects (29 percent) who took Treximet werepain-free at two hours compared to 11 percent of subjects who took placebo,

-- Nearly one-quarter of subjects (24 percent) who took Treximet achievedsustained pain-free results from two through 24 hours compared to 9 percent ofsubjects who took placebo.

Secondary endpoints were: pain-freedom at 30 minutes, one hour and fourhours; sustained pain-relief from two through 24 hours; pain relief at 30minutes, one hour, two hours and four hours; use of rescue medication within24 hours post-dose; intermediate sustained pain-relief at one to two hours andtwo to four hours; intermediate sustained pain-freedom at one to two hours andtwo to four hours; and incidence of neck and sinus pain, photophobia,phonophobia and nausea at two and four hours. Treximet was superior toplacebo in producing pain-freedom and pain-relief at four hours post-dose,sustained pain-relief from two through 24 hours, as well as producingintermediate sustained pain-relief and pain-freedom at two through four hours(and one to two hours for intermediate pain-freedom). In addition,significantly fewer subjects taking Treximet required the use of rescuemedication compared to those taking placebo. The other secondary endpointswere not statistically significant.

Treximet was generally well-tolerated, with no new or unexpected adverseevents, reported as 11
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