Contact:
Rachel Bloom
Zeneca Pharmaceuticals
302-886-7858
[email protected]
EMBARGOED UNTIL THURSDAY, APRIL 30, 1998, 7 A.M.
NEW STUDY SHOWS MIGRAINE AND DEPRESSION MAY BE TREATED TOGETHER SUCCESSFULLY
ZOMIG(TM) (zolmitriptan) Remains Safe When Taken with Antidepression Treatment
MINNEAPOLIS-April 30, 1998-Migraine and depression, two commonly linked conditions, may now be treated together, according to results of a new study presented today at the 50th annual meeting of the American Academy of Neurology. The new oral medication for the treatment of acute migraine from Zeneca Pharmaceuticals, ZOMIG(TM) (zolmitriptan), is safe when taken with the antidepression treatment fluoxetine, commonly known by its trade name Prozac.1 Other migraine therapies, including sumatriptan, have been shown to interact with fluoxetine.2
An estimated 25 to 30 million people suffer from migraine in the United States.3 Studies of migraine and depression show consistent evidence of a substantial association between these two conditions because of their common link-serotonin.4 With the onset of a migraine attack, serotonin activity in the brain changes dramatically. Changes in serotonin activity within the brain also are thought to be involved in depression.5
"Given that depression and migraine often occur together, it is likely that some patients may take ZOMIG (TM) (zolmitriptan) and an antidepressant at the same time," said Gerardo Torres, M.D., US Project Physician for ZOMIG. "Our research suggests migraine patients who suffer from depression may treat both diseases safely with this combination of drugs."
The objective of the study was to investigate the effect of multiple doses of fluoxetine on the blood levels and safety profile of ZOMIG(TM) (zolmitriptan). In this randomized, double-blind, two-period crossover study, 20 healthy male and female volunteers received fluoxetine or placebo daily for 28 days. With the last dose of fluoxetine or placebo, subjects took a single oral dose of ZOMIG in the fasting state.
Results of the study show fluoxetine has no effects on the blood levels of ZOMIG(TM) (zolmitriptan) or its metabolites. ZOMIG was well tolerated when given alone or with fluoxetine. There was a small clinically insignificant increase in blood pressure following ZOMIG, which was unaltered by fluoxetine.
ADDITIONAL STUDIES ON ZOMIG TO BE PRESENTED DURING THE AAN MEETING
Several other studies will be presented at the AAN meeting. Highlights of each follow:
-- Single Dose of ZOMIG Maximizes Migraine Relief: 95 and 93 percent response rates with 2.5-mg and 5-mg tablets respectively In an open-label study of 2,499 patients to date with more than 49,784 migraine attacks, 66 percent of attacks were treated with a single dose of 2.5 or 5 mg. The two-hour headache response rate for the treatment of moderate to severe migraine with ZOMIG(TM) (zolmitriptan) 2.5 and 5 mg was 95 percent and 93 percent, respectively. ZOMIG 2.5 and 5 mg were well tolerated.
-- ZOMIG Effective in Treating Migraine Related to Menses and With Use of Oral Contraceptives Researchers conducted a post-hoc analysis of the 4,700-patient database to determine the clinical efficacy of ZOMIG(TM) (zolmitriptan) in women with migraine related to menses and with use of oral contraceptives. Results show two-hour headache response rates of 65 percent and 69 percent for ZOMIG 2.5 and 5 mg, respectively, in women who experienced migraine with menses. Two-hour headache response rates were similar in women taking oral contraceptives, with 67 and 62 percent for ZOMIG 2.5 and 5 mg, respectively.
-- ZOMIG is Well Tolerated in Patients With or Without Liver Disease To compare the tolerability of ZOMIG(TM) (zolmitriptan) in healthy patients and those with liver disease, investigators conducted an open, parallel group study of 37 subjects. Results show ZOMIG was well tolerated at four times the recommended dose of 2.5 mg, and the incidence of adverse events was similar in all groups. Investigators concluded that migraine patients with moderate liver disease require no dosage reduction. In patients with severe liver disease, the dosage may need to be lowered and blood pressure monitored.
-- ZOMIG Does Not Interact With Sedative In a randomized, double-blind, placebo-controlled, six-period, crossover trial, researchers evaluated the effects of ZOMIG(TM) (zolmitriptan) on the ability to perform complex, cognitive tasks (psychometric) and whether ZOMIG remained safe when taken with the sedative diazepam. The primary conclusion was that ZOMIG had no effect on psychometric testing performance, and there was no clinically significant interaction with diazepam.
-- Age, Gender, and Kidney Function Dosage Adjustments for ZOMIG Not Necessary Groups of healthy patients over 65 and those with kidney failure were compared with healthy adult subjects under 45 to evaluate differences in the tolerability or function of ZOMIG(TM) (zolmitriptan). Results show that older and younger subjects taking ZOMIG had similar blood levels. In addition, no dose- adjustment based on gender was required. Finally, there were no clinically significant changes in blood level based on kidney impairment. Thus, researchers were able to conclude that dosage adjustments for ZOMIG are not necessary based on age, gender, or kidney function.
-- ZOMIG Consistently Effective in Treating Migraine To assess how consistent the efficacy of ZOMIG(TM) (zolmitriptan) is, investigators conducted placebo-controlled, single-attack trials in which patients were treated with ZOMIG 2.5 and 5 mg. Two-hour headache response rates were consistent (65 and 67 percent) and significantly better than placebo (19 to 36 percent). Thus, researchers concluded ZOMIG is consistently effective in treating migraine.
-- New Migraine Tool Helps Assess Headache-Associated Disabilities To help assess the debilitating effects of migraine on patients, researchers compared the new Migraine Disability Assessment (MIDAS) Questionnaire with physician perceptions based on patient histories. Results show the individual physician-reported scores correlated highly with the MIDAS score.
HEADACHE SYMPOSIUM AT THE AAN MEETING
In addition, the science of migraine will be expanded during a scientific symposium on new headache treatments, which was supported in part by an educational grant from Zeneca Pharmaceuticals. The symposium will be presented from 8 to 10 pm, Thursday, April 30, during the AAN meeting.
BACKGROUND ON ZOMIG
ZOMIG 2.5-mg and 5.0-mg tablets were cleared for market by the US Food and Drug Administration in November 1997 for treatment of acute migraine with or without aura in adults. ZOMIG(TM) (zolmitriptan) was made available by prescription in pharmacies nationwide in January.
ZOMIG(TM) (zolmitriptan) is contraindicated for patients with uncontrolled hypertension, ischemic heart disease, or other significant underlying heart disease. Patients with coronary heart disease, or those predisposed, should be fully evaluated by their physician prior to initiation of therapy with ZOMIG. In addition, ZOMIG should not be administered to patients who are hypersensitive to zolmitriptan or any of its inactive ingredients. ZOMIG should only be used where a clear diagnosis of migraine has been established. As with other serotonin agonists, sensations of tightness, pain, pressure, and heaviness have been reported after treatment with ZOMIG tablets in different regions of the body, including the chest.
In a safety database of more than 4,000 patients, ZOMIG(TM) (zolmitriptan) was well-tolerated. Adverse events reported by patients were mostly mild or of moderate intensity and the most common included asthenia (lack of energy), nausea, dizziness, somnolence (drowsiness), and paresthesia (feelings such as tingling, numbness or itching).
In the US, Zeneca Inc. is a $3.4 billion bioscience business with approximately 7,500 employees. Zeneca Inc. is a wholly-owned subsidiary of the UK-based Zeneca Group PLC (NYSE:ZEN), a major $8.6 billion international bioscience business engaged in the research, development, manufacture, and marketing of ethical (prescription) pharmaceuticals, agricultural and specialty chemical products, and the supply of health care services.
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Prozac is a trademark of Eli Lilly. 2Joffe, RT, Sokolov, ST: Co-administration of fluoxetine and sumatriptan: the Canadian experience. Acta Psychiatr Scand. (Denmark), June 1997; 95 (6) p551-2. 3 Stewart WF, Lipton RB, Celentano DD, et al: The epidemiology of severe migraine headaches from a national survey: Implication of projections to the United States population. Cephalagia. 1991; 11 (suppl 11) 37. 4 Merikangas, KR, Stevens, DE: Comorbidity of migraine and psychotic disorders. Neurol Clin. (United States), Feb. 1997; 15 (1), 115-23. 5 Constantine, Lynne M. Scott, Suzanne. Migraine: The Complete Guide. New York, 1994, p.39.
NOTE: For full prescribing information, please call Rachel Bloom at 302-886-7858 or visit the ZOMIG web site at www.zomig.com.
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