Dublin, Ireland - November 18, 2004 - Elan Corporation, plc today announced that PRIALT(tm) (ziconotide) has received a positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP), the human medicines scientific body of the European Medicines Agency. The CHMP has recommend that Prialt be indicated for the treatment of severe, chronic pain in patients who require intrathecal (IT) analgesia. The CHMP's positive recommendation will now be proposed for final marketing approval by the European Commission. Final approval customarily follows the CHMP's recommendation in approximately three months.
Today's recommendation is based in part on the Phase III clinical trial, Study 301, which evaluated the efficacy and safety of IT Prialt in patients with severe chronic pain who were inadequately controlled by, or intolerant to, opioids. Prialt has been awarded orphan drug status in the European Union; products with orphan drug status are for the diagnosis, prevention or treatment of life-threatening or very serious rare diseases or conditions.
"We are encouraged by the Committee's positive recommendation and look forward to receiving final approval in the near future," said Lars Ekman, MD, executive vice president, and president Research and Development, Elan. "Elan remains committed to making this unique orphan therapy available to those patients in Europe who are burdened by severe chronic pain, many of whom are currently without adequate relief."
Severe chronic pain is defined as pain lasting longer than six months and commonly occurs after major trauma or failed back surgery, but may be caused by an initial injury or accident.
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