Pubdate: 18 September 1997 Source: Orange County Register news, page 7 Contact: 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.