BOSTON, June 27 /PRNewswire-FirstCall/ -- Patients suffering from probable migraine, which is defined as a sub-type of migraine that meets all but one of the migraine diagnostic criteria, frequently have difficulty finding effective treatment. To date, no available migraine-specific medications have proven effective in treating this migraine sub-type. However, according to new data, Treximet is the first migraine-specific medication to demonstrate pain-free results in patients with probable migraine without aura. These data were presented today at the 50th Annual Scientific Meeting of the American Headache Society in Boston.
Typically, this migraine sub-population experiences pain symptoms which may include pain on one side of the head, moderate to severe pain, throbbing pain or worse pain when moving or bending, but do not present with an associated symptom, such as nausea or vomiting or sensitivity to light and sound.
“The study findings are promising, as helping patients with this condition find adequate pain relief is often challenging,” stated Stephen Silberstein, MD, professor of neurology and director of the Jefferson Headache Center at Thomas Jefferson University, and a lead author of the study. “Treximet was superior to placebo in producing pain-freedom at two hours and sustained pain-freedom from two through 24 hours.”
Recently approved for the acute treatment of migraine attacks with or without aura in adults, Treximet is the first and only migraine product designed to target multiple mechanisms of migraine by combining a triptan and an anti-inflammatory pain reliever in a single tablet. The recommended dosage for patients prescribed Treximet is one tablet and should only be used where a clear diagnosis of migraine has been established. Treximet is not indicated for 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 probable migraine of at least six months and moderate to severe pain lasting at least four to 72 hours. Subjects were randomized to Treximet or placebo, and were allowed to take a second dose of Treximet or their usual medication at two hours following initial treatment. Co-primary endpoints were pain-free at two hours and sustained pain-free from two through 24 hours.
Treximet was superior to placebo in producing pain-freedom at two hours post-dose and sustained pain-free results from two through 24 hours:
-- Nearly one-third of subjects (29 percent) who took Treximet were pain-free at two hours compared to 11 percent of subjects who took placebo,
-- Nearly one-quarter of subjects (24 percent) who took Treximet achieved sustained pain-free results from two through 24 hours compared to 9 percent of subjects who took placebo.
Secondary endpoints were: pain-freedom at 30 minutes, one hour and four hours; sustained pain-relief from two through 24 hours; pain relief at 30 minutes, one hour, two hours and four hours; use of rescue medication within 24 hours post-dose; intermediate sustained pain-relief at one to two hours and two to four hours; intermediate sustained pain-freedom at one to two hours and two to four hours; and incidence of neck and sinus pain, photophobia, phonophobia and nausea at two and four hours. Treximet was superior to placebo in producing pain-freedom and pain-relief at four hours post-dose, sustained pain-relief from two through 24 hours, as well as producing intermediate 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 rescue medication compared to those taking placebo. The other secondary endpoints were not statistically significant.
Treximet was generally well-tolerated, with no new or unexpected adverse events, reported as 11 percent of subjects taking Treximet compared to 7 percent of subjects taking placebo. The most common drug-related adverse events (greater than or equal to 2 percent and greater than placebo) reported in this study were dizziness and dry mouth.
This study was funded by GlaxoSmithKline.
About GlaxoSmithKline
GlaxoSmithKline -- one of the world’s leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For detailed company information, see GlaxoSmithKline’s website: www.gsk.com.
Important Safety Information About Treximet
Prescription Treximet is indicated for the acute treatment of migraine attacks, with or without aura, in adults. Treximet should only be used where a clear diagnosis of migraine headache has been established.
Treximet may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Treximet contains a non-steroidal anti-inflammatory drug (NSAID). NSAID-containing products cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
Treximet is contraindicated in patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes and in patients with other significant underlying cardiovascular diseases. Treximet should not be given to patients in whom unrecognized coronary artery disease is predicted by the presence of risk factors without a prior cardiovascular evaluation. Treximet should not be given to patients with uncontrolled hypertension because the components have been shown to increase blood pressure.
Concurrent administration of MAO-A inhibitors or use of Treximet within two weeks of discontinuation of MAO-A inhibitor therapy is contraindicated. Treximet and any ergotamine-containing or ergot-type medication (like dihydroergotamine and methysergide) should not be used within 24 hours of each other. Since Treximet contains sumatriptan, it should not be administered with another 5-HT1 agonist.
Treximet is contraindicated in patients with hepatic impairment. Treximet is contraindicated in patients who have had allergic reactions to products containing naproxen. It is also contraindicated in patients in whom aspirin or other NSAIDs/analgesic drugs induce the syndrome of asthma, rhinitis, and nasal polyps. Both types of reactions have the potential of being fatal. Treximet is contraindicated in patients with hypersensitivity to sumatriptan, naproxen, or any other component of the product.
Cerebrovascular events have been reported in patients treated with sumatriptan. In a number of cases, it appears possible that the cerebrovascular events were primary. It is important to advise patients not to administer Treximet if a headache being experienced is atypical.
The development of a potentially life-threatening serotonin syndrome may occur with triptans, including treatment with Treximet, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs). NSAID-containing products, including Treximet, should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding.
Treximet should not be used in late pregnancy because NSAID-containing products have been shown to cause premature closure of the ductus arteriosus. Treximet should not be used during early pregnancy unless the potential benefit justifies the potential risk to the fetus.
For complete Prescribing Information for Treximet please visit www.gsk.com.
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