FDAnews
www.fdanews.com/articles/69125-ireland-s-elan-wins-european-approval-for-prialt-painkiller

Ireland's Elan Wins European Approval for Prialt Painkiller

February 24, 2005

Irish pharmaceuticals producer Elan Corporation has received EU marketing approval for its Prialt (ziconotide) treatment, indicated for chronic pain in patients undergoing intrathecal analgesia. The move follows a positive opinion in November 2004 by the European Medicines Agency, and the company has received "orphan-drug" status on the product.

Prialt is one of class of non-opioid analgesics known as N-type calcium channel blockers, originally synthesised from studies of marine snails. The Irish firm has high hopes for Prialt, and is also confident that its recently US FDA-approved Tysabri (natalizumab) therapy for multiple sclerosis will reverse recent losses. Elan reported a US$375.9mn loss in 2004, although it expects a return to profitability in 2006.