The Food and Drug Administration Tuesday approved a new potent painkiller developed by
that is based on a toxin produced by a small marine snail.
The non-narcotic drug, Prialt, is designed for patients with severe chronic pain who can't tolerate other therapies, including morphine. Prialt is delivered into the fluid surrounding the spinal cord through a pump.
Although the drug doesn't have the sales potential of Tysabri, Elan's multiple sclerosis drug approved by the FDA late last month, the approval marks
another big step in Elan's effort to escape from serious financial mishaps earlier in the decade and to rebuild its stock price and reputation.
Elan's stock gained $1.14, or 4.5%, to $26.74 after the announcement.
The drug will be available in late January. Elan will market Prialt by itself. The company has enlisted
as its marketing and development partner for Tysabri.
Elan also has sought approved for Prialt in the European Union. The company said it expects a decision by regulators during the first quarter of 2005.
Prialt's path through the FDA moved at a snail's pace. Elan submitted an application to the FDA in 2000. But a year later, the FDA said the company needed to conduct more tests, using lower doses than the company had originally proposed.
"This therapy represents a significant treatment option for patients who do not have adequate pain relief from other therapies," said Dr. Mark Wallace, an investigator on the clinical studies of the drug, in a press release issued by Elan. "Furthermore, Prialt is not associated with the risk of addiction." He is associate professor of clinical anesthesiology at the University of California at San Diego.
Prialt is the synthetic equivalent of venom found in Conus magus, a marine snail. Prialt belongs to a class of drugs called N-type calcium channel blockers, which apparently block nerves from transmitting pain signals.
The most reported side effects in the Prialt clinical trials were dizziness, unsteady and abnormal gait and confusion. However, Elan noted that "severe psychiatric symptoms and neurological impairment" may be associated with the drug. The company said patients with a history of psychosis shouldn't receive the drug. All patients should be monitored for hallucinations as well as changes in mood or consciousness, Elan said.