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Executive Summary

GLAXO's ORAL SUMATRIPTAN 187-PATIENT STUDY INDICATES MIGRAINE RELIEF IN 70% of patients treated with the 5-HT(BRACKET)1] receptor agonist. Joseph Sargent, MD, Menninger Clinic, reported the results of the study on July 1 to the Fifth International Headache Congress in Washington, D.C. The double-blind, placebo- controlled, parallel-group study was conducted by 15 U.S. physicians and looked at the effects of 25 mg, 50 mg, and 100 mg oral sumatriptan (Imitrex) in 187 patients over a four-hour clinical reporting period. Relief was judged by a four-point self- reporting scale. Four hours after taking the drug, 70% of the sumatriptan group reported "mild or no pain," compared to 19% on placebo; 40% of the sumatriptan group reported themselves to be pain free, compared to 11% of the placebo group, Sargent reported. Oral sumatriptan takes about an hour to be effective. By dose, "an analysis of secondary measures of efficacy" showed the 100 mg dose to be the most effective six-to-12 hours after dosing. The group taking the highest tested dosage also experienced the greatest incidence of "meaningful relief" four hours after dosing and showed the highest improvement in disability and nausea symptoms, Sargent said. He reported "no serious adverse events." Data on the oral form of sumatriptan was presented for the first time publicly at the headache congress. Glaxo said that a paper on an oral sumatriptan study is being considered now at one of the refereed journals. Data on two Phase III trials on injectable Imitrex were published in the June 5 Journal of the American Medical Association. Glaxo has been developing the oral form of sumatriptan for use by migraineurs who can anticipate their migraine, for example, those with pre-headache auras; for those who do not suffer from severe nausea that would preclude taking an oral product; or those for whom early therapy may ward off an attack. Glaxo filed the NDA for oral Imitrex on Dec. 17. The company filed an NDA for a subcutaneous form of the drug in mid-1990. Glaxo's Anthony Fox, MD, reported separately that "among 2,495 patients" in placebo-controlled, double-blind studies of sumatriptan tablets, "the range of adverse events was similar to that observed following injection of the drug." He went on to note that "the frequency of the various adverse events was lower with sumatriptan tablets than with injection." In studies of subcutaneous sumatriptan, the drug has been associated with tingling, dizziness and "warm-hot sensations," in addition to injection-site reactions ("The Pink Sheet" June 10, T&G-9), and one myocardial infarction. Fox noted that there is "no evidence is available to indicate whether this event was drug related."

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