Elan cleared to market Prialt in Europe

This approval follows a positive opinion in November 2004 by the European Committee for Medicinal Products for Human Use (CHMP), the human medicines scientific body of the European Medicines Agency (EMEA).

Marketing approval of Prialt (ziconotide) was based on the treatment of more than 1,000 patients, including three pivotal clinical studies, which evaluated the efficacy and safety of intrathecal (IT) Prialt in patients with severe chronic pain that was not adequately managed despite a regimen of systemic and/or IT analgesics.

Prialt, developed by scientists at Elan, is in a class of non-opioid analgesics known as N-type calcium channel blockers. It is the synthetic equivalent of a naturally occurring conopeptide found in a marine snail. Research suggests that the mechanism of action of Prialt works by targeting and blocking N-type calcium channels on nerves that transmit pain signals.

“Prialt is the first new IT analgesic for severe chronic pain in many years and in many cases represents an effective alternative to currently available opioids, with no evidence of the development of tolerance to treatment over time, drug addiction or respiratory depression,” said Dr Ann Ver Donck, one of the clinical investigators for Prialt and pain therapy specialist at the Multidisciplinary Pain Centre, Brugge, Belgium.