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FDA Approves Frova (Frovatriptan Succinate) for Migraines

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DUBLIN, IRELAND — November 9, 2001 — Elan Corporation, plc, announced that the U.S. Food and Drug Administration (FDA) approved Frova™ (frovatriptan

succinate) 2.5 mg tablets, for the acute treatment of migraine attacks with or without aura in adults.

Approximately 10 percent of the U.S. population suffer from migraine attacks. Of these 27 million sufferers, over 50 percent remain under-diagnosed or under-treated. The U.S. market in 2001 for migraine therapy is expected to be approximately $1.4 billion for the overall triptan class with the oral triptans representing $1.2 billion.

The efficacy and tolerability of Frova was demonstrated in five randomized, double blind, placebo-controlled trials. According to Arthur Elkind, MD, Director of the Elkind Headache Center, Mt. Vernon, New York, “My experience with frovatriptan in a long-term, open label trial indicates it is an effective treatment and provides a high degree of patient satisfaction.”

In a market in which only 29 percent of patients report they are very satisfied with their migraine therapy, the benefits of Frova make it an important alternative therapy in the treatment of migraine for many patients. Migraine attacks typically last four to seventy-two hours. Frova 2.5 mg tablets have a 26-hour half-life. Frova may represent an important advancement in the treatment of migraine headache as no other currently marketed triptan has a half-life of more than six hours. Stephen Silberstein, MD, Director, Jefferson Headache Center, Philadelphia, Pennsylvania said, “The addition of frovatriptan, with its long half-life, gives physicians another alternative to managing patients.”

Frova is a 5-HT receptor agonist that binds with a high affinity for the

5HT(1B) and 5HT(1D) receptors and is believed to act on extracerebral, intracranial arteries and to inhibit excessive dilation of these vessels in migraine. Frova was well-tolerated in clinical trials. The side effects that occurred most frequently following administration of Frova 2.5 mg tablets (in at least 2 percent of patients, and at an incidence of greater than or equal to 1 percent compared to placebo) were dizziness, paresthesia, headache, dry mouth, fatigue, flushing, hot or cold sensation and chest pain.

SOURCE: Elan Corporation, plc

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