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| |  New Option, Frova (Frovatriptan Succinate), Now Available To Treat Migraine Sufferers SMYRNA, GA., and DUBLIN, IRELAND -- June 19, 2002 -- The newest migraine treatment, Frova™ (frovatriptan succinate) 2.5 mg tablets, is now widely available throughout the United States. Approved by the U.S. Food and Drug Administration for the acute treatment of migraine attacks with or without aura in adults, Frova is from the well-known class of drugs called triptans. However, Frova has a half-life of 26 hours, allowing its active ingredient to remain in the blood for at least 20 hours longer than any other triptan.(1) Elan Corporation, plc and UCB Pharma, Inc. will co-promote the product in the United States. Migraines, often referred to as "debilitating headaches" by the estimated 25 to 30 million sufferers in the United States, are characterized by recurring symptoms of moderate to severe, throbbing pain on one or both sides of the head, nausea and sensitivity to light and sound. The average migraine lasts more than 24 hours,(2) with a range of four to 72 hours.(3) A recent study has shown that seven out of 10 migraine sufferers are dissatisfied with their current migraine therapy.(4) New Frova treats the pain of a migraine by constricting targeted blood vessels in the brain. In clinical studies, less than half the patients taking Frova needed to augment the treatment of their pain with additional medications, including aspirin. "Triptans have revolutionized the treatment of migraine and have helped millions with migraines live more normal lives," explained Roger K. Cady, M.D., director of the Headache Care Center, Primary Care Network in Springfield, Mo., and an investigator in the clinical trials of Frova. "However, despite these advances, there is still room for improvement, as not everyone gets adequate relief from their migraine treatment. One important reason is that many times the headache returns even after treatment. "Frovatriptan is a promising new addition to current migraine therapies because it remains active in the body for a long period of time. This unique characteristic may be important because a migraine attack itself can last for days." The efficacy and tolerability of Frova was demonstrated in five randomized, placebo-controlled clinical trials of 4,129 patients. Frova significantly reduced migraine pain versus placebo. Patients treated with Frova also reported significant relief in symptoms associated with migraines, including nausea and sensitivity to light and sound. Available in 2.5 mg tablets, Frova should be taken with fluids at the onset of a migraine. If adequate headache relief is not achieved with the first dose, a second dose can be taken two hours later. Only one percent of patients withdrew from clinical trials because of adverse events, most of which were reported to be mild or moderate and transient. Adverse events that were reported by at least two percent of patients included dizziness, fatigue, paresthesia (a burning or prickling sensation), flushing, headache, dry mouth, hot or cold sensation and chest pain. About UCB Pharma, Inc. About Elan Corporation, plc For complete prescribing information on Frova, please visit http://www.elan.com. (1) Haas DC. Headache Cybertext. "Migraine Therapy: The Triptans." http://www.upstate.edu/neurology/haas. (2) Lipton RB, Hamelsky SW, Stewart WF. Epidemiology and impact of headache. In: Wolff' s Headache and Other Head Pain. 7th ed. Oxford University Press. 2001:85-107. (3) American Council for Headache Education. "Personal Life: How Does Migraine Impact the Sufferer's Life?" http://www.achenet.org/impact/life.shtml. (4) Lipton RB, Stewart WF. Headache. 1999;39(suppl 2):S20-S26.
SOURCE: UCB Pharma, Inc.
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