New Drug Is Approved to Treat Chronic Pain

On Tuesday, the Food and Drug Administration approved Prialt (ziconotide), a new drug for hard-to-treat pain associated with cancer, AIDS, and neuropathies that may improve pain management. The drug -- as much as 1,000 times more powerful than morphine and delivered directly into the fluid surrounding the spinal cord -- is considered a last resort for chronically suffering patients, rather than a first-line pain drug.

Prialt is a synthetic form of the venom used by Conus magus, a South Pacific cone snail, to stun its prey. It works by blocking the calcium channels in nerve cells that transmit pain signals.

"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," said Robert Meyer, director of FDA's Office of Drug Evaluation II. "At this point we don't see this class of drug expanding to general use," he said. It is so potent that it cannot be taken in pill form; even small amounts of the drug could be dangerous to the heart and possibly other organs.

Lars Ekman, president for global research and development for Elan, the drug's manufacturer, said as many as 100,000 people in the United States may be helped by Prialt. The drug's researchers believe it may become an alternative to opioid drugs such as Oxycontin and morphine, and it may ultimately provide hope for severely affected patients dependent on medications such as Celebrex, Aleve, and the now-withdrawn Vioxx.

Expected on the market by next month, Prialt will have a "black box" warning of its risks, which include hallucinations and psychosis in vulnerable people.

Mary Pat Aardrup, executive director of the National Pain Foundation, a nonprofit education group, deemed FDA's approval a "red-letter day" for pain patients. "To have another pain drug in an entirely new class is very exciting and very hopeful."

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