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STUDY POINTS TO NEW HOPE FOR MIGRAINE SUFFERERS IN 50-YEAR-OLD DRUG

STUDY POINTS TO NEW HOPE FOR MIGRAINE SUFFERERS IN 50-YEAR-OLD DRUG
 TORONTO, June 22 /PRNewswire/ -- In a new study to be presented here later this week, a single injection of DHE-45(R) (dihydroergotamine mesylate) Injection, USP, marketed by Sandoz Pharmaceuticals Corporation, dramatically relieved headache pain in nearly half of migraine patients within 30 minutes, and in most patients within an hour.
 The clinical observations afforded by this open-design study, as well as others, are part of a trend pointing to similarities in the efficacy of 50-year-old DHE-45 and the emerging new drug, sumatriptan. The office-based clinical field trial involved 38 U.S. clinics and 311 migraine patients. It is one of eight studies on DHE-45 to be presented at the 34th annual scientific meeting of the American Association for the Study of Headache, to be held June 26-28 in Toronto.
 Migraine afflicts more than 20 million Americans. A wide range of symptomatic medications exist for the severe headache pain and other debilitating symptoms of the condition. But physicians have been searching for therapies that will quickly eradicate migraine at its neurogenic source, rather than merely masking the pain.
 "This study underscores that we have two such therapies -- a well- established drug whose significance we are only just now beginning to fully comprehend, and an emerging agent that may soon be available as well," said Paul K. Winner, DO, principal investigator, who is president of the Florida Association for the Study of Headache and an active researcher in headache.
 Key results of the study include:
 -- Rapid, dramatic relief of pain. Pain disappeared completely or was reduced to only mild pain in nearly half of patients (46 percent) within 30 minutes of a single 1 mg intramuscular injection of DHE-45. This dramatic pain relief was achieved in 72 percent of patients after one hour. Adverse events were reported by only 9 percent of patients, and these were generally mild and short-lived.
 -- Effective at second dose, if required. DHE-45 was shown in this study to be effective at a second dose administered after one hour, if required. Seventy percent of the 88 patients who required a second injection had mild to no pain within 60 minutes of the extra dose. This data suggests an interesting trend that, upon further study, may differentiate DHE-45 from the emerging drug, sumatriptan. Although not directly comparable studies, controlled studies published last year in the New England Journal of Medicine and the Journal of the American Medical Association found a second dose of sumatriptan at one hour to afford little additional benefit in patients who did not respond well to their first dose.(1,2)
 -- Rapid return to normal activity. The rapid, non-sedating action of DHE-45 enabled patients to quickly resume normal activity -- 58 percent within 30 minutes of treatment and 75 percent within an hour. "This is a tremendous boon to sufferers, who are accustomed to losing the rest of their day when a migraine strikes," said Winner. "Our results show that patients experiencing an acute migraine episode can come into the office, receive a simple injection, and return to work in an hour or two."
 -- Well-tolerated by patients. The study also suggests that DHE-45 is well-tolerated by patients whose migraines are accompanied by nausea, even when the drug is administered without anti-nausea medication. In the study, 62 percent of patients had nausea at the outset, 40 percent had nausea at 30 minutes, and 30 percent at 60 minutes. Roughly half were given anti-nausea medication at the outset. The presence of nausea was similar in those who received the medication and those who did not. "Many physicians administer anti-nausea medication as a matter of routine. Our data suggest that this may not be necessary in all patients with nausea," said Winner. "Further study on this issue should yield additional data that may better guide our use of anti- nausea drugs, which can be sedating."
 Developed by Sandoz during the 1940s, DHE-45 is now undergoing major rediscovery throughout the medical community as a serotonin agonist that rapidly eradicates migraine at its source without dependency or rebound. DHE-45 was synthesized to provide an alternative to ergotamine tartrate for patients debilitated by the nausea and vomiting that commonly accompany a migraine attack. Although it is an ergot alkaloid, DHE-45 differs chemically and functionally from ergotamine tartrate. DHE-45 provides comparable efficacy with less gastrointestinal upset.
 DHE-45 is currently available as an intravenous and intramuscular injection in the United States. In Canada, DHE-45 is additionally approved for subcutaneous administration. Manufacturer Sandoz is now awaiting approval to market, in addition, a nasal spray formulation of the drug.
 References: (1) Ferrari, MD, et al. Treatment of migraine attacks with sumatriptan. New England Journal of Medicine 1991; 325: 316-321.
 (2) Cady, RK, et al. Treatment of acute migraine with subcutaneous sumatriptan. Journal of the American Medical Association 1991; 265: 2831-2835.
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CN -- NE002 -- 2266 06/22/92 09:47 EDT
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Date:Jun 22, 1992
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