Wall Street Journal - December 29, 2004
Sara Schaefer-Munoz, Staff Reporter of The Wall Street Journal

Prialt, generically called ziconotide, is a synthetic version of sea snail venom manufactured by the Irish drug-maker Elan Corp. Approved for sale in the U.S. yesterday by the Food and Drug Administration, it is expected to be available to physicians and patients in late January and could generate as much as $250 million in peak sales, Elan said. Final European approval for the drug is expected in early 2005.

About 120,000 patients, mostly people with diseases such as cancer and AIDS , are candidates for the painkiller, part of a new type of non-narcotic analgesics known as peptide channel blockers. Most of these patients have failed to get relief from other drugs, such as morphine.

"Prialt offers an important new option for patients," said Lars Ekman, president of research and development for Elan. "Many of them are at the end of their life and are having intractable pain."

Prialt is the equivalent of the naturally occurring venom that tropical sea snails use to incapacitate prey. Researchers believe it works by blocking calcium channels on the nerves that transmit pain signals to the brain. It is released into the fluid surrounding the spinal chord by an internal or external pump.

A major benefit is that it can be used long-term without the dose wearing off and without it having to be increased significantly, researchers found. By contrast, opiate-based drugs such as morphine have the drawback of being addictive, making patients drowsy and losing their effect if administered long-term.

Prialt's side effects include dizziness, confusion, and difficulty walking, researchers said. "Because this is a population where they have such few options, this is an important therapeutic advance even given the adverse effects we have seen," said Robert Meyer, a director of an FDA office of drug evaluation.

The drug can also have psychiatric side effects, such as hallucination, if taken in high doses. Dr. Ekman said that one of the advantages of Prialt is that it can be administered at relatively low doses and still be effective.

Prialt's approval comes as safety concerns continue over the painkillers Vioxx, Celebrex and naproxen, which is sold over-the-counter under the brand name Aleve. Studies have suggested that these drugs carry an elevated risk of cardiovascular problems.

The approval was based on the treatment of more than 1,200 patients in three clinical trials, the company said. In a trial involving 111 cancer patients, patients who received Prialt instead of a placebo showed a 53% improvement in pain reduction, researchers said.

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