Irish drug company Elan today announced that its has successfully completed trials of
its chronic pain treatment drug , Prialt.
Based on the positive results, Elan expects to file an application with the US Food and Drug Administration (FDA) in the second quarter of 2004 and to bring the treatment to market no later than the first quarter of 2005.
Prialt is the first in a new class of non-opioid analgesics known as N-type calcium channel blockers, administered intrathecally for the treatment of severe chronic pain. Elan submitted an application for approval for marketing Prialt in the European Union in May 2003.
Dr Lars Ekman, Elan's president of R&D, said the company was "very encouraged" by the definitive findings with Prialt and believe that this is significant news for patients suffering with severe chronic pain.
The FDA had previously issued an approvable letter for Prialt, in which the agency had requested additional information. This trial was conducted in response to the FDA's clinical request and designed with their input, studying 220 patients with severe chronic pain to demonstrate the efficacy and safety of lower doses of Prialt.
About two million patients in the US with chronic pain fail to respond to existing comprehensive treatment. Of these, about 300,000 may be considered as potential candidates for intrathecal treatment, which could include Prialt.