Treximet Treatment for Migraine Headaches

Migraine headache (neurological syndrome 2) is a severe recurrent throbbing and pounding pain involving one temple, located in the forehead and around the eye or back of the head. 1 The severity of the throbbing pain lasts from 4 to 72 hours, accompanied by gastrointestinal upsets. 2 The frequency of a migraine headache occurrence may happen several times a month, once a month or few times during the year. 3 In the United States twenty-eight million Americans suffer from migraine headaches and unfortunately only half of suffers are diagnosed by physicians. More women suffer from migraine headaches than men. 1 "Migraine typically begins in childhood, adolescence or early adulthood and may become less frequent and less intense as you grow older." Hereditary link to migraine is known to occur within families. 3 Significantly migraine headache is severe enough to cause missed work and loss of productivity, costing some $15 million annually according to a CNBC (Consumer News and Business Channel) report. 8

"Nevertheless, migraine still remains largely undertreated and underdiagnosed." The cause of migraine headache attributed to a combination of an enlargement of blood vessels (vasodilatation) and subsequent release of chemicals from nerve fibers that coil around the blood vessels. As a result of these factors attributed to migraine headache, the temporal artery enlarges lies outside the skull (under the skin of the temple). The release of chemicals, as a result of temporal artery stretching the nerves; coil around the artery cause pain and inflammation. As the enlargement of the artery increases, level of pain is magnified. Migraine attacks affect the sympathetic nervous system, which adversely affects the function of the intestines thus causing vomiting, nausea, and diarrhea. Subsequently oral medications ineffectively fail to be absorbed by the small intestines. Also, the adverse affect on the sympathetic nervous systems leads to skin appearing pale, cold hands and feet, sensitivity to light and blurred vision. Secondary cause of migraine headache may be attributed to a brain tumor. 1

Preceding a migraine headache forty to sixty percent of suffers experience (symptoms): Irritability, sleepiness, and cravings for sweet and salty foods. 1

Common factors that trigger a migraine headache include: Certain type of foods, stress, hormonal changes, changes in sleep and wake patterns, physical factors, sensory stimuli, physical factors, changes in the environment and medications may trigger a migraine. 3

In April 2008, The Food and Drug Administration approved GlaxoSmithKline and PROZEN Incorporated sale of Treximet (Previous name Trexima 5) for acute treatment of migraine attacks in adults. 4 In 2005, the FDA requested additional data regarding Treximet before granting approval for distribution in April 2008. 7 "Treximet is a combination of sumalriplan (85mg 4) (the active ingredient in the migraine drug Imitrex) and the anti-inflammatory painkiller naproxen sodium (500 mg 4) (the active ingredient in Aleve and Naprosyn)." 5 Treximet will be sold as tablets in 25 mg, 50 mg, and 100 mg strengths. 4 According to GlaxoSmithKline and Pozen during clinical trials (Among 3,700 migraine participant sufferers 4), Treximet worked more effectively to treat migraine than either one of the ingredients alone, with relief lasting from two to 24 hours. Also, the medication reduced symptoms of nausea and sensitivity to light and sound linked to migraine headaches. 5 Dr. Stephen Silberstein professor of neurology and director of the Jefferson Headache Center at Thomas Jefferson University and investigator who participated in clinical trials said: "Migraine patients want their medicine to work early and to continue to provide relief." 4

During clinical trials taking Treximet common side effects reported dizziness, nausea, chest discomfort, sleepiness, pain in the neck, throat and jaw, tightness and pressure, numbness or tingling, and dry mouth. 5 Naproxen sodium ingredient of Treximet may cause gastrointestinal problems including bleeding and ulceration, and perforation of the stomach or intestines which could be fatal, especially among elderly patients. 6 GlaxoSmithKline and Prozen do not recommend Treximent for patients who have heart disease, risk developing perilous cardiovascular clotting as an adverse reaction. 5 Also, the medication should not be prescribed for use in late pregnancy, may adversely affect the pregnancy 6. Treximet should be administered only as prescribed (Two tablets in 24 hours) at the lowest possible dosage for treatment and shortest time needed. "Some medicines can interact with Treximet and cause serious side effects." 6 Treximet will be available for sale in U.S. pharmacies by mid - May 2008. 4

"Drug company Prozen has received the $20 million it was scheduled to get from GlaxoSmithKline after approval of the companies' migraine drug Treximent." 9

References:

1.) Migraine Headache - http://www.medicinenet.com/migraine_headache/page2.htm

2.) Migraine - http://en.wikipedia.org/wiki/Migraine

3.) Migraine - http://www.mayoclinic.com/health/migraine-headache/DS00120/DSECTION=2

4.) Treximet - http://www.gsk.com/media/pressreleases/2008/2008_us_pressrelease_10034.htm

5.) FDA OKs New Migraine Drug Treximet - http://www.webmd.com/migraines-headaches/news/20080416/fda-oks-new-migraine-drug-treximet

6.) Treximet - http://www.drugs.com/treximet.html

7.) Pozen says safety data for migraine drug promising, shares up - http://uk.reuters.com/article/hotStocksNews/idUKBNG7241520080115

8) Treximet Approved for Migraines - http://www.evitamins.com/news.asp?id=614720

9.) GlaxoSmithKline pays $20M to Pozen - http://www.bizjournals.com/triangle/stories/2008/04/28/daily8.html?ana=from_rss