FOR IMMEDIATE RELEASE
CONTACT:
Rachel Bloom
Zeneca Pharmaceutical
302/886-7858
[email protected]
Judith Auchard
302/886-3638
MIGRAINE TREATMENT FROM ZENECA CLEARED FOR MARKET IN THE U.S.
ZOMIG (zolmitriptan) OFFERS NEW OPTION FOR MIGRAINE SUFFERERS
WILMINGTON, DEL.--November 26,1997 --For the 23 million Americans who suffer from the debilitating effects of migraine, a new drug may offer relief. ZOMIG (zolmitriptan) 2.5mg. and 5.0mg. tablets, an oral medication for the treatment of acute migraine with or without aura in adults, was cleared for marketing today in the United States. ZOMIG is a product of the Zeneca Group of Companies and is marketed by Zeneca Pharmaceuticals in the United States.
"Clinical trials have shown ZOMIG tablets to be an effective treatment for migraine headache," said Alan Rapoport, M.D., a ZOMIG investigator involved in clinical trials. Dr. Rapoport is director of The New England Center for Headache in Stamford, Conn. "In multiple studies of migraine sufferers, ZOMIG has been well-tolerated and provided relief from moderate or severe pain associated with migraine."
Current theories proposed to explain the etiology of migraine suggest that headache symptoms are due to local cranial vasodilation and/or to the release of sensory neuropeptides through nerve endings in the trigeminal system. The therapeutic activity of ZOMIG, a selective oral 5-HT1B/1D receptor agonist for the treatment of migraine headache, can most likely be attributed to the agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release. In preclinical animal models, it was shown that ZOMIG may also act centrally to inhibit brain stem electrical activity thought to be involved with central transmission of pain signals to higher brain centers.
In the ZOMIG clinical program which included eight placebo and non-placebo controlled clinical trials, and a one year open label safety study, enrolling more than 4,700 patients, the
safety and efficacy of ZOMIG was assessed. In the five placebo-controlled trials, results showed that ZOMIG provided headache relief two hours after treatment significantly more often than placebo. During a 24-hour period, ZOMIG proved considerably more effective than placebo in providing relief from moderate or severe pain and reduced the use of other pain medications. In a long-term study, ZOMIG demonstrated similar results in treating multiple migraine attacks for up to one year.
For patients with migraine associated photophobia (sensitivity to light), phonophobia (sensitivity to sound), and nausea at baseline, there was a decrease incidence of these symptoms following administration of ZOMIG as compared to placebo.
ZOMIG is contraindicated for patients with uncontrolled hypertension, ischemic heart disease, or other significant underlying heart disease. Patients with coronary heart disease, or those predisposed to it, 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 5-HT1B/1D 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 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).
Migraine is the most common neurological disease in developed countries. An estimated 23 million Americans suffer from the recurrent intense headaches and visual and gastrointestinal
ZOMIG Market Clearance/3
disturbances that can be completely disabling, forcing the sufferer to abandon everyday activities until the pain recedes, usually between several hours and a few days.
ZOMIG is manufactured for the U.S. market by IPR Pharmaceuticals, Inc., a member of the Zeneca Group of Companies, in its Carolina, Puerto Rico plant, and will be available by prescription soon in pharmacies nationwide. Patients should consult their physician for a specific dosing regimen.
"Zeneca Pharmaceuticals has been dedicated for more than 30 years to the research and development of effective therapies for CNS [central nervous system] disorders," said Robert C. Black, President of Zeneca Pharmaceuticals. "The market clearance of ZOMIG is an important step in Zeneca achieving its aim of becoming a global leader in CNS treatment."
Other CNS products developed by Zeneca worldwide include agents for the management of anesthesia, anxiety, depression, epilepsy and psychotic disorders. Zeneca dedicates about 21 percent of its $659 million in research and development resources to the discovery and trial of new CNS treatments. ZOMIG was launched earlier this year in the United Kingdom, Sweden, Germany, and Finland. Regulatory approval of ZOMIG has also been given in nine other markets, including France, Italy, and Spain.
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 (NYSE:ZEN), 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.
NOTE: For full prescribing information, please call Nancy Brown at 302/886-7719 or visit the Zeneca Pharmaceuticals web site at www.usa.zeneca.com/pharm.
Lipton, RB, Stewart WF: Migraine in the United States: A review of epidemiology and health care use. Neurology 1993; 43 (suppl 3) S6-S10.
RSS