US FDA has approved Elan Corporation's Prialt (ziconotide intrathecal infusion) for the management of severe chronic pain in patients for whom intrathecal (IT) therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies or IT morphine.
FDA approval of Prialt was based on the treatment of more than 1,200 patients and three phase III clinical trials, which evaluated the efficacy and safety of Prialt in patients with severe chronic pain that was not adequately managed despite a regimen of systemic and/or IT analgesic and other drugs.
"Prialt is an innovative new treatment and an important therapeutic advance for patients who suffer from severe chronic pain," said Lars Ekman, executive vice president and president, Research and Development, Elan.
"The first new IT analgesic approved in more than two decades, Prialt offers an important new option for physicians and patients, based on one of the largest and most comprehensive IT analgesic safety databases available," added Ekman.
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 Prialt's novel mechanism of action works by targeting and blocking N-type calcium channels on nerves that ordinarily transmit pain signals, the company informed in a release.
"Taken together, the findings from the Prialt clinical trials are conclusive evidence that this therapy represents a significant treatment option for patients who do not have adequate pain relief from other therapies," Mark Wallace, associate professor of Clinical Anesthesiology, Department of Anaesthesiology, University of California San Diego; director, Centre for Pain and Palliative Medicine; and an investigator for Prialt pivotal studies said.
Prialt is expected to be available to physicians and patients in the United States in late January.