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Zeneca Pharmaceuticals Zeneca Pharmaceuticals
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STUDY SUGGESTS ZOMIG PROVIDES RELIEF FOR DIFFICULT TO TREAT MENSTRUAL MIGRAINE AND MIGRAINE IN WOMEN USING ORAL CONTRACEPTIVES
SAN ANTONIO, Texas-October 22, 1997- Results of clinical trials for ZOMIG (zolmitriptan), an investigational oral medication for the treatment of acute migraine, demonstrate that the compound may provide relief of migraine headache associated with and without menstruation, as well as migraine in women using oral contraceptives. These clinical trial data were presented at the American Osteopathic Association Research Conference, held October 19-23 in San Antonio. ZOMIG is a product of Zeneca Pharmaceuticals. Hormone replacement therapy and oral contraceptive use have been shown to alter the frequency and intensity of migraine headaches in women.(1) Early studies also suggest that low estrogen levels may be associated with headaches frequently reported during the placebo week of oral contraceptive use.(2,3)
"Migraine associated with menses and migraine in women using oral contraceptives are generally considered difficult to treat and have been shown to be resistant to many migraine therapies," said Elizabeth Loder, M.D., Director of Headache Management Program, Spaulding Rehabilitation Hospital in Boston. "Clinical research indicates ZOMIG to be consistent and effective in relieving the headache pain and other symptoms such as nausea, vomiting, and sensitivity to light and sound associated with these types of migraine headache."
ZOMIG is a selective 5-HT1B/1D (5-hydroxytriptamine) serotonin receptor agonist designed specifically for the acute treatment of migraine headache. ZOMIG is currently not available and is presently under review by the U.S. Food and Drug Administration (FDA). A new drug application for ZOMIG was submitted to the FDA on November 26, 1996. -more-
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In order to understand the potential clinical benefits of ZOMIG, specifically in women with migraine associated with menses or in women who use oral contraceptives, the clinical response rates in these two subgroups of patients have been collected for a combined presentation. Data were collected to examine the clinical response of ZOMIG in migraine associated with menses at a 2.5-mg dose (trials 017,042) and a 5.0-mg dose (trial 017). Additionally, clinical trials have evaluated the clinical response of a 2.5-mg dose of ZOMIG (trials 017, 042) in women using oral contraceptives and two trials examined the clinical response of a 5.0-mg dose (trials 017, 008). All of these studies were double-blind, placebo-controlled, randomized trials.
Primary results of this study analysis demonstrated similar responses to ZOMIG in women who had migraine headache associated with or without menses. Additionally, ZOMIG showed a similar clinical response in migraine in women using oral contraceptives as compared to women not taking oral contraceptives.
In a safety database of more than 3,000 people, ZOMIG appeared well-tolerated. Adverse events reported by patients were mostly of mild or moderate intensity. The most common adverse events included asthenia (lack of energy), nausea, dizziness, somnolence (drowsiness), and parathesia (feelings such as tingling, numbness, or itching).
Migraine is among the most common neurological diseases in developed countries. An estimated 23-25 million Americans suffer from the recurrent intense headaches and visual and gastrointestinal disturbances which can be completely disabling. Sufferers often may be forced to abandon everyday activities until the pain recedes, usually between several hours and a few days.(4) Zeneca Pharmaceuticals is a business unit of Zeneca Inc., a $3.1 billion bioscience business with approximately 7,200 employees in the United States. Zeneca Inc. is a wholly-owned subsidiary of the U.K.-based Zeneca Group PLC, a major $9 billion international bioscience business engaged in the research, development, manufacturing, and marketing of ethical (prescription) pharmaceuticals, agricultural and specialty chemical products, and the supply of health care services. # # #
(1) Kudrow L. The relationship of headache frequency to hormone use in migraine. Headache. 1975;15(1):36-49.
(2) Somerville BW. A study of migraine in pregnancy. Neurology. 1972;22(8):824-828.
(3) Somerville BW. Oestrogen-withdrawal migraine. I. Duration of exposure required and attempted prophylaxis by premenstrual estrogen administration. Neurology. 1975;25(3):239-244.
(4) Lipton, RB, Stewart WF: Migraine in the United States: A review of epidemiology and health care use. Neurology 1993; 43 (suppl 3) S6-S10.
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