Looks like it might be a pain killer of last resort, still very
encouraging and non-narcotic. -- MZ

FDA approves synthetic drug 1,000 times stronger than morphine

By Marc Kaufman

The Washington Post



WASHINGTON — A synthetic form of a sea-snail venom was approved
yesterday by the Food and Drug Administration as a novel approach to
treating severe, chronic pain.

The drug, called Prialt, was approved for hard-to-treat pain
associated with cancer, AIDS and neuropathies. Based on a compound
found in the poison of the South Pacific cone snail, it controls pain
in an entirely new way — by blocking the calcium channels in nerve
cells that transmit pain signals — and may have broad implications for
pain management.

Because it is as much as 1,000 times more powerful than morphine, it
is considered a last resort for long-suffering patients, rather than a
first-line pain medication.

"This drug is very exciting because it's a very potent analgesic but
isn't a narcotic," said Richard Rauck, of Wake Forest University
Medical Center and the Carolinas Pain Institute. Rauck, an
investigator for one of the clinical trials that led to yesterday's
FDA approval, said he found the drug to be "effective in almost all
types of chronic pain it's been studied in."

What will limit the use of Prialt is that it cannot be taken in pill
form. It must be delivered directly into the fluid surrounding the
spinal cord, which carries it to the brain without affecting other
organs. Because it is so potent, tiny amounts of the drug could be
dangerous to the heart and possibly other organs.

"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 the FDA's Office of Drug Evaluation II.

Nonetheless, Lars Ekman, president of Élan Inc. of Ireland, the drug's
maker, said up to 100,000 people in the United States might be helped
by the drug.

About 50,000 patients already use devices that pump morphine directly
into the spinal column, he said, and many of them may want to try
Prialt because opioids can gradually lose their effectiveness. In
addition, many patients in severe pain who take pain pills may want to
try the spinal-cord route if the drug involved is not an opioid, he
said.

"There are thousands of people out there who have pain like a bad
toothache all day and night, week after week," Ekman said. "Many of
these people have tried morphine, and it either didn't work or made
them unable to function."

Prialt is a synthetic form of the venom that the Conus magus snail,
which lives in tropical saltwater shallows, uses to stun passing prey.



Prialt, expected to reach the market next month, will come with a
"black box" warning — the FDA's strongest warning — regarding its
risks, which include hallucinations and even psychosis.

Despite Prialt's limitations, Mary Pat Aardrup, executive director of
the National Pain Foundation, a nonprofit education group, called it 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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