Elan Corporation, plc has been granted marketing approval for Prialt (ziconotide) by the European Commission (EC) for the treatment of severe, chronic pain in patients who require intrathecal (IT) analgesia.
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. Marketing approval of Prialt was based on the treatment of more than 1,000 patients, including three pivotal clinical studies, which evaluated the efficacy and safety of IT Prialt in patients with severe chronic pain that was not adequately managed despite a regimen of systemic and/or IT analgesics, an Elan release said.
Lars Ekman, executive vice president and president, Research and Development, Elan asserts, "Prialt can offer new hope for patients in Europe as the first new IT analgesic approved in more than two decades. We are deeply gratified that physicians and patients now have a significant option for the treatment of severe chronic pain, an area in which there is tremendous unmet medical need."
Prialt has been awarded orphan drug status in the European Union, which designates it as a product used for the diagnosis, prevention or treatment of life-threatening or very serious rare disorders or conditions.
Prialt, developed by scientists at Elan, is in a class of non-opioid analgesics known as N-type calcium channel blockers. Prialt is the synthetic equivalent of a naturally occurring conopeptide found in a marine snail known as Conus magus. Research suggests that the mechanism of action of Prialt works by targeting and blocking N-type calcium channels on nerves that transmit pain signals, the release says.
The approval of Prialt was based on three independent pivotal studies, each of which demonstrated significant improvement on the Visual Analog Scale of Pain Intensity, a well-accepted pain outcome measure.