NARCOTIC LOZENGES OK'D TO ALLEVIATE CANCER PAIN

WASHINGTON -- Thousands of cancer patients will soon have a powerful new way
to fight severe pain -- a raspberry-flavored "narcotic lollipop" loaded with
a painkiller that can seep into the bloodstream faster than any pill.

Approved Thursday by the government, the prescription drug Actiq has been
controversial because the white lozenge on a plastic stick looks somewhat
like a lollipop, a word used to its manufacturer's distress. Critics fear it
could entice children, with fatal consequences.

Actiq can kill children, the Food and Drug Administration warned. It even
could kill adults whose bodies are not accustomed to narcotics, or it could
be abused by drug addicts.

So the government made manufacturer Anesta Corp. take unusually strict steps
to prevent Actiq's misuse. Among the requirements is packaging Actiq in a
heavy foil that requires scissors to open, difficult for very young
children. Anesta also will provide patients with free locks for cabinets
where they store Actiq and child-resistant "fanny packs" for patients who
want to keep the drug nearby.

The FDA approved Actiq despite the concerns because it provides the first
way for cancer patients to control pain attacks at home. Relief can begin
within minutes; only powerful drug injections usually given in hospitals
work as quickly.

It "can provide rapid and dramatic relief," said Michael Friedman, the FDA's
acting commissioner and a cancer specialist.

But don't call Actiq a lollipop, Anesta officials pleaded Thursday. "It's
become a very important point to us, implying it's serious medicine and not
candy," said company president Thomas King.

Actiq will not be sold until March, because Anesta needs more time to
produce child-resistant packaging. Lozenges will cost $6 to $15 each.

Pain is a major problem for cancer patients.

About 800,000 with chronic pain also suffer "breakthrough pain," sudden,
agonizing episodes that break through the regular painkillers taken several
times each day. The attacks can last up to two hours.

Actiq, 10 times more potent than morphine, lets patients rapidly get just
the amount of medicine needed during each crisis.

It is made of fentanyl, a narcotic painkiller currently available in
injections and skin patches. Putting it in a lozenge lets the drug seep
through mouth tissues into the bloodstream in minutes. Patients hold the
lozenge between their gums and cheeks -- not under the tongue, where it's
less effective -- until they feel relief.

Like all narcotics, Actiq can cause side effects, including sleepiness,
dizziness, nausea and constipation, the FDA said. Because Actiq can suppress
breathing, the biggest danger is if young children mistakenly use it or if
teens experiment with it.

The FDA reluctantly let Anesta use a sugary raspberry flavoring, because
fentanyl alone tastes so bad that patients could not tolerate it, Friedman
said.

But the drug is only for patients who are prescribed opiate-based chronic
painkillers, Friedman said, and Anesta will check monthly prescription
records to spot doctors who prescribe it erroneously.

Checked-by: Don Beck