Drugmakers including King Pharmaceuticals Inc. and Johnson & Johnson won’t need to register doctors or patients as part of a plan to minimize the risks of long-acting painkillers, U.S. regulators said.
The Food and Drug Administration proposed the first standardized restrictions, aimed at fostering safety while ensuring patients keep access to the medicines, in a notice posted today on the agency’s website. The recommendations will be reviewed at a July 22-23 meeting of the FDA’s advisory committees on drug safety and anesthetic and life-support drugs.
Makers of 24 extended-release pain pills and patches were ordered by the FDA in February 2009 to help devise a plan to restrict use of the products to instances in which benefits exceed risks. The program would affect more people than any risk-management measure adopted to date by the FDA, and the agency is leaning toward an education-focused plan, with voluntary training by the companies and patient handouts.
“Nearly 4 million patients are prescribed long-acting or extended-release opioids annually, and enrolling this many patients in a patient registration system would be an enormous undertaking with unpredictable effects on patient access,” FDA staff members said in a 374-page report released for the panels’ review.
King, of Bristol, Tennessee, rose 11 cents, or 1.4 percent, to $8.03 at 4:01 p.m. in New York Stock Exchange composite trading. The company sells a long-acting morphine drug called Embeda and is developing new painkillers to deter abuse. J&J, the New Brunswick, New Jersey-based maker of the Duragesic pain patch, rose 75 cents, or 1.3 percent, to $59.45.
Other long-acting painkillers include OxyContin, made by closely held Purdue Pharma LP in Stamford, Connecticut; and Opana, from Endo Pharmaceuticals Inc. in Chadds Ford, Pennsylvania.