Data from a clinical study to be reported later this week pointsto similarities in treating migraine headaches between a 50-year-old drug, DHE-45, and an emerging new drug,sumatriptan.
In the study, DHE-45 (dihydroergotamine mesylate) Injection,USP, marketed by Sandoz Pharmaceuticals Corp., dramaticallyrelieved headache pain in nearly half of migraine patientswithin 30 minutes, and in most patients within an hour.
DHE-45 was also shown to be effective at a second doseadministered after one hour, if required, relieving pain in 70percent of the 88 patients who required a second injection.Although not directly comparable studies, controlled studiespublished last year in the New England Journal of Medicine andthe Journal of the American Medical Association found a seconddose of sumatriptan at one hour to afford little additionalbenefit in patients who did not respond well to their first dose.
Glaxo Holdings plc, which last year launched its migraine drugImigran, also known as sumatriptan, said it could not yet tellthe impact on its products of the DHE-45 study. Sumatriptan issimilar to serotonin, a naturally occurring neurotransmitter. Itplays a role in several biological functions, including mood,sleep, digestion and cardiovascular performance.
DHE-45, developed by Sandoz during the 1940s, is undergoinga major rediscovery throughout the medical community as aserotonin agonist that rapidly eradicates migraine at its sourcewithout dependency or rebound.
The office-based clinical field trial involved 38 U.S. clinics and311 migraine patients. It is one of eight studies on DHE-45 tobe presented at the 34th annual meeting of the AmericanAssociation for the Study of Headache, to be held June 26-28 inToronto.
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