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CHRONIC PAIN MEDICATION PRIALT GETS GREEN LIGHT

December 29, 2004

Elan has been granted FDA approval for Prialt for the management of severe chronic pain in patients who are intolerant of traditional pain medications, such at IT morphine or systemic analgesics.

Prialt (ziconotide intrathecal infusion) is part of a class of nonopioid analgesics known as N-type calcium channel blockers. The drug is the synthetic equivalent of a naturally occurring conopeptide found in a marine snail known as Conus magus. Research suggests Prialt works by targeting and blocking N-type calcium channels on nerves that ordinarily transmit pain signals.

FDA approval was based on three Phase III clinical trials involving more than 1,200 patients. Prialt is expected to be available to physicians and patients in the U.S. in late January. Pricing will be available at that time.