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Ziconotide in chronic pain requiring intraspinal analgesia: orphan drug

Ziconotide is a man-made equivalent of a molecule composed of a 25-amino acid chain, which is found in the venom of a fish-eating marine snail, Conus magus. Ziconotide blocks the action of specific molecules found in nerve tissue, called N-type voltage-sensitive calcium channels. These molecules play an important role in chronic pain. Ziconotide is expected to decrease pain by blocking the function of these molecules.

Ziconotide (intraspinal use) was not marketed anywhere in the world for the treatment of chronic pain requiring intraspinal analgesia, nor designated as an orphan medicinal product elsewhere for this condition, at the time of submission. The Committee for Orphan Medicinal Products (COMP) adopted on 23 May 2001 a positive opinion recommending the grant of the above-mentioned designation.

In 2005 Ziconotide (intraspinal use) (Prialt) was authorised in the European Union for the treatment of severe, chronic pain in patients who require intrathecal (IT) analgesia.

Source: http://www.ema.europa.eu/pdfs/human/comp/opinion/025204en.pdf