February 17, 2011
By Staff Reporter
The synthetic drug has natural roots. Researchers interest was piqued when learning of the process by which a marine snail known as Conus magus would paralyze its victims using a small amount of venom before killing it.
The process was discovered at the University of Utah in 1979 by a freshman student studying toxins produced by cone snails.
It is said to control pain in an entirely new way, by blocking the calcium channels in nerve cells that transmit pain signals. The drug can only be injected into fluid surrounding the spinal cord by external or implanted pumps. It must be delivered directly into the fluid surrounding the spinal cord, which carries it to the brain. Because of the drug’s potency, tiny amounts of the drug could be dangerous to the heart and possibly other organs.
It is expected to have broad implications for the future of pain management.
The business of managing pain is a growing one. With an aging population and new advances in medicine, clinics and treatments spring up almost overnight.
Elan is hoping to have the drug available to U.S. in late January, and expects to get European approval soon after that.
“Severe chronic pain” is classified as that which lasts longer than six months and can be a result of multiple causes, such as failed back surgery, injury, accident, cancer, AIDS, and various nervous system disorders.
The drug is aimed at patients for whom intrathecal therapy is warranted, and who are not responding well to other treatments, which are usually narcotic and morphine-based. Intrathecal therapy is that which is administered through a pump, and in this case, to the spinal cord.
“Prialt is an innovative new treatment and an important therapeutic advance for patients,” said Lars Ekman, executive vice president and president for eesearch and development at Elan.
Said Robert Meyer, director of the FDA’s Office of Drug Evaluation II, “This drug is for patients in chronic and severe pain who are not getting substantial and meaningful relief with oral opiates or are having unacceptable side effects with them.”
It is first new IT analgesic approved in more than two decades.
With pain drugs such as OxyContin, and more recently, Vioxx undergoing public scrutiny, Elan is hoping Prialt may eventually they also may provide an alternative for severely affected.
Considered up to 1,000 times more powerful than morphine, the side effects include severe psychiatric symptoms and neurological impairment.
For that reason, Prialt is now considered a last resort for long-suffering patients, as opposed to a first-line pain medication.
Prialt was tested in more than 1,200 patients in three Phase III trials. The longest treatment done in tests was seven years.
Elan is focused on therapies that deal specifically with neurodegenerative diseases, autoimmune diseases and severe pain.
With this advance, Elan is looking to make a big splash in the international pharmaceutical world. Shares were up 3 percent the week following the approval of the drug.
In December, Elan announced the $120 million sale of its European sales and marketing business. Still, revenues from remaining operations were up 31 percent in the last quarter of 2004, and it is expected Prialt will build on that.
Elan hopes the drug might help up to 100,000 people in the United States.
Pricing on Prialt is yet to be determined. This is the second FDA approval for two Elan drugs in as many months. In November, the FDA approved its multiple sclerosis drug Tysabri.