Panel calls for OK of drug lollipop

By: PAUL RECER, The Associated Press

Photo: PAINKILLING CANDY: Prototype packaging for Actiq, a
raspberryflavored narcotic lollipop, is designed to make the off white
pops unattractive to children, its maker said. Actiq would be used to treat
breakthrough pain in cancer patients.

GAITHERSBURG, Md. A raspberryflavored lollipop loaded with narcotic
painkiller for treatment of cancer patients was recommended for federal
approval Wednesday, despite concerns about accidental poisoning of children.

A Food and Drug Administration advisory panel voted unanimously that the
benefit to cancer patients from the painkilling candy far outweighed the
risk of young children being harmed.

"Some kid, somewhere, somehow is going to do this (eat the lollipop)," said
panel member Suzanna Brown, a Portland, Ore., nurse. "But do we deny this
benefit to cancer patients for that reason?"

FDA approval is required before the lollipop can be sold, but the agency
generally follows recommendations of advisory panels.

The lollipop, Actiq, is to be manufactured by Anesta Corp. of Salt Lake
City and marketed with Abbott Laboratories.

The drug is actually a sugar based lozenge on a stick. It is loaded with
fentanyl citrate, a narcotic commonly used in other forms to treat cancer
pain. The lollipop is offwhite and stick bears a large "Rx" mark.

Anesta officials said the product is designed to be unattractive to
children and is packaged in a foil pouch that studies showed could not be
opened by children up to age 4.

Along with the packaging, the company said it was lowering the danger of
abuse by limiting and controlling distribution.

Actiq is designed for cancer patients who already are receiving opiates to
control chronic pain. The lollipop will be used for quick relief from what
is called "breakthrough pain," sudden spasms of pain so severe that they
break through the roundtheclock dosage used to control chronic pain.

Steven A. Shoemaker of Anesta said the company recognized the attraction
the lollipop might have for children and has designed an extensive program
of education, careful distribution and patient instructions to lower the
risk of poisoning.

Asked what would happen if a child did consume the lollipop, Shoemaker
admitted: "The consequences would be lifethreatening. There is a definite
risk."

But members of the committee generally said the benefits to some 1 million
cancer sufferers who are in constant pain outweighed the risk.

The lollipop will provide almost immediate relief, the company said, for
patients suddenly racked by terrible pain from their cancer. The drug is
absorbed in the mouth and starts work within minutes. Its effects last for
only about 15 minutes, but that is usually long enough to relieve
breakthrough pain.

Pain in cancer is a major problem, since most cancer patients are treated
at home and often must manage their own discomfort, said Mary A. Simmonds
of the American Cancer Society.

"There currently is no comparable product without a needle," Simmonds said
of the lollipop.

Dr. Laura F. McNicholas of the Philadelphia Veterans Administration Medical
Center warned the committee of a serious risk of drug abuse from marketing
the lollipop.

"My nightmare is that college kids will be out there having a lollipop
party, and some of them will not wake up in the morning," she said.

Shoemaker said the drug would be carefully monitored and if abuse is
reported the company will "send in a SWAT team" to investigate the problem
and take measures to prevent the illegal distribution.

Anesta and Abbott already are marketing a narcotic lollipop that is used
only in hospitals.