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Title: Maxalt Shows Fast Relief Of Migraine Pain And Nausea
URL: http://www.pslgroup.com/dg/AD3EA.htm
Doctor's Guide
September 3, 1998


LONDON, ENGLAND -- Sept. 3, 1998 -- A novel formulation of Merck's Maxalt (rizatriptan) has been shown to be fast and effective in delivering pain relief to migraine sufferers, according to a new clinical study, presented at the 12th Migraine Trust International Symposium.

The formulation is the first and only migraine medicine to be produced as a wafer, which dissolves rapidly on the tongue and may be taken without liquids. The 10 mg wafer provided relief of migraine as early as 30 minutes for some patients.

"Fast pain relief is one of the most important aspects of a migraine medication," explained Dr. Marek Gawel, neurologist of the Headache Research Unit at the Sunnybrook Hospital University of Toronto Clinic. "Having rizatriptan available in a wafer formulation will allow even someone with nausea to find relief."

These investigational drug and novel formulation are currently under review by the Health Protection Branch of Health Canada

The rizatriptan 10 mg wafers were studied in a randomized, blinded, placebo-controlled study involving 547 patients. The primary objective of this study was to determine the percentage of patients reporting pain relief within two hours after dosing. The study also examined the percentage of patients who were pain free at various time intervals and those who experienced improvement in functional disability. Other measurements included the percentage of patients with sensitivity to light and sound (photophobia and phonophobia) and tolerability to the medication.

The study results showed that at all time points (half-hour intervals up to two hours) -- significantly more patients taking rizatriptan 10 mg wafers reported pain relief and a pain-free response, compared with patients taking placebo. In fact, in as early as 30 minutes, a significant number of patients taking rizatriptan 10 mg wafers reported pain relief, compared with placebo. Patients taking rizatriptan 10 mg wafers also were significantly more likely to become pain free at 30 minutes, compared with placebo.

At two hours, significantly more patients taking rizatriptan 10 mg wafers reported:

-- pain relief (74 per cent versus 28 per cent)
-- complete freedom from pain (42 per cent versus 10 per cent)
-- reduced incidence of nausea (26 per cent versus 46 per cent)
-- reduced incidence of photophobia (44 per cent versus 77 percent)
-- reduced incidence of phonophobia (39 per cent versus 66 per cent)
-- improvement in ability to function normally (46 per cent versus 15 per cent)

Rizatriptan 10 mg wafers were well tolerated by most patients in this study.

Rizatriptan has been evaluated in studies with more than 3,500 patients around the world who treated more than 25,000 migraine attacks. Researchers at Merck's Neuroscience Research Centre discovered rizatriptan, a potent, highly selective 5HT1B/1D agonist. Pre-clinical studies have shown that rizatriptan constricts swollen blood vessels around the brain, preventing the release of neuropeptides or chemicals that cause further inflammation around those vessels and blocks pain signals from sensory nerves to the brain. These three actions may play a role in the clinical efficacy of rizatriptan.

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