FDA APPROVES NEW DRUG FOR CANCER, WARNS PATIENTS

WASHINGTON - hundreds of 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 say it could entice children, with fatal consequences. Actiq
can kill children, the Food and Drug Administration said. It could
even kill adults whose bodies are not accustomed to the narcotic, or
it could be abused by drug addicts.

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

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

"For the right patient, this is a very substantial improvement in the
quality of . . . life," said Michael Friedman, the FDA's acting
commissioner and a cancer specialist. It "can provide rapid and
dramatic relief."

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

Pain is a major problem for cancer victims. About 800,000 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 is made of fentanyl, a narcotic painkiller available in
injections and skin patches.

Putting fentanyl in a lozenge lets the drug seep through mouth tissues
into the bloodstream in minutes. Patients can hold the lozenge between
their gums and their 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 cautioned. But because
Actiq can suppress breathing, the biggest danger is if young children
mistakenly use it or if teen-agers, learning that fentanyl is an
addictive controlled substance, experiment with it.

The FDA reluctantly let Anesta use a sugary raspberry flavoring,
because fentanyl alone tastes so bad that patients couldn't have
tolerated it, Friedman said.

Checked-by: Rich O'Grady