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GLAXO IMITREX INJECTABLE (SUMATRIPTAN) STOPS MIGRAINE PAIN IN HALF

Executive Summary

GLAXO IMITREX INJECTABLE (SUMATRIPTAN) STOPS MIGRAINE PAIN IN HALF of acute migraine patients who received the injectable 5HT[1] receptor agonist in two Phase III placebo- controlled trials reported in the June 5 Journal of the American Medical Association. The two studies found that at one hour after injection with 6 mg of Glaxo's sumatriptan succinate, 356 of 734 patients who had received the drug (49%) were "completely free of pain compared with 35 (9%) of 370 patients who had received placebo." The studies, led by Roger Cady, MD, Shealy Institute for Comprehensive Health Care (Springfield, Mo.) and supported by Glaxo, found that at one hour, 515 (70%) of the 734 who received a single dose of subcutaneous sumatriptan reported "mild pain..... or no pain..... compared with 81 (22%) of..... placebo patients." Of the non-placebo group, 49% were completely without pain and 99% of the drug group (355 patients) "were still pain free at two hours." Patients with residual headaches received a second injection of 6 mg sumatriptan or placebo. A comparison at two hours of sumatriptan-treated patients, who had received either one or two doses, with the placebo group "prior to any rescue medication, revealed that 81% of those receiving sumatriptan had migraine pain relief compared with 34% of those receiving placebo." Not only did subcutaneous sumatriptan relieve migraine pain, the drug also was effective in reducing migraine-associated nausea and photophobia (light intolerance) better than placebo, the researchers reported. "This suggests that concomitant analgesic and anti-emetic drugs may be unnecessary." Patients showed improvement in those symptoms "within 20 minutes" of receiving sumatriptan. At one hour, 43% of those administered sumatriptan had photophobia versus 76% on placebo. Also, 27% had nausea one hour after injection with the drug compared to 51% of placebo patients. Twenty minutes after administration, "more" sumatriptan receivers also reported "normal or slightly impaired working ability than did placebo-treated patients," as compared to a pretreatment assessment of severely-impaired working ability, the study reports. Sumatriptan's effects also were fairly long-lasting, the study found. Of the 734 patients who received the drug, 69% (511) were still pain free when discharged from the clinic compared to 22% of those on placebo, and 34% (250 of the 734) stayed completely pain- free for 24 hours compared with 11% (40) of the 370 placebo- treated patients. The researchers noted that there was a higher percentage of sumatriptan patients leaving the clinic pain-free despite the greater use of rescue medication by placebo patients (20% versus 59%). Cady, et al. pointed out that many migraineurs, including those in the study, frequently self-medicate in anticipation of a recurring migraine attack in spite of being free of pain. Within 24 hours of the trial, 61% of the sumatriptan group took rescue medication compared to 88% of the patients on placebo. Adverse effects caused seven patients (six receiving sumatriptan) to wi thdraw from the parallel trials. The adverse effects seen with injectable sumatriptan included tingling, dizziness, "warm-hot sensations" and injection-site reactions such as stinging or redness. Also, more patients in the sumatriptan group experienced drug-related adverse effects: 96% versus 79% of the placebo patients. Most of the reactions "began within minutes of the injection and lasted less than one hour," the study notes. Glaxo filed an NDA for subcutaneous sumatriptan in mid-1990 and filed for a slower working oral form of the drug on Dec. 17. Glaxo anticipates approval by late 1992/early 1993 and has indicated that FDA may give the drug a priority review as a clear therapeutic advance over existing migraine treatments.
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PS019294

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