FDA Will Restrict New Painkiller
The Food and Drug Administration approved a powerful long-acting painkiller called Palladone, but the decision camewith restrictions designed to avoid the abuse and addiction problems that have arisen with similar drugs. The new drug is similar to OxyContin, a controversial medicine made by the same company, closely held Purdue Pharma LP, and it has an active ingredient that is even more potent. That has raised concerns about the potential for abuse at a time whenmisuse of prescription drugs — particularly painkillers — is rising.
Purdue says Palladone has a different formulation from OxyContin, which is available generically. It is a capsule, not a tablet, and has a time-release function that should make it more difficult, though not impossible, to misuse. Approved by the FDA in 1995, OxyContin became widely abused partly because it could be crushed, unlocking the time-release mechanism and delivering a potent high.
The plan for Palladone includes doctor education and efforts to track whether the drug is diverted to illegal use, by surveying law-enforcement sources, poison-control centers and other entities. The drug also will come with a warning that says it should be used only for "persistent moderate to severe pain in patients requiring continuous, around-the-clock analgesia," and only in patients already taking opioids. Including OxyContin, sales of narcotic painkillers totaled $5.6 billion last year, up 20% from the year before, according to IMS Health, a market-research company. An estimated 2.8 million people had at some point used OxyContin without a medical need, according to a 2003 federal study. That was up from 1.9 million in 2002.
