FDA move may raise painkiller overdose deaths, some say
A decision by federal regulators to allow generic versions of a heavily abused painkiller to be sold without tamper-resistant features will lead to more overdose deaths on Long Island and across the country, experts warned.
The U.S. Food and Drug Administration on Friday denied a request by Endo Health Solutions to block generic versions of Opana ER -- a decision that the drug company argued would lead to more abuse than its brand-name medication.
The FDA's decision came as a surprise because the agency had recently issued tougher guidelines aimed at preventing prescription pain pill abuse -- and had signaled that easily abused drugs would no longer reach the market.
"Mark my words: We will see an increase in abuse and overdoses directly related to this misguided and dangerous decision," said Dr. Thomas Jan, a Massapequa pain-management and addiction specialist who serves on a Nassau County heroin abuse task force.
Endo reformulated Opana -- an opioid drug containing oxymorphone -- with tamper-resistant features last year in an effort to make the pills harder to crush, snort and inject. The company's request to block generic versions for safety reasons would have protected its expiring patent on Opana.
But the FDA announced Friday that it had denied Endo's petition, in part because the reformulated Opana can still be abused and might in fact be easier to inject than the original.
Endo, which has an office in Westbury, said it was disappointed with the FDA's decision.
The FDA announcement came hours after the agency again delayed a decision on whether to approve a powerful new painkiller -- Zohydro ER -- that addiction experts say would likely be heavily abused.
The delay spurred criticism from the company that produces Zohydro, which is a purer, more potent version of hydrocodone medication.
"Unfortunately for all our stakeholders, including patients . . . we are still faced with further delay from the FDA," Roger Hawley, chief executive of Zogenix, the San Diego-based company that makes the drug, said in an earnings call with investors Thursday. "To our knowledge, this sort of delay is unprecedented."
The FDA missed an initial March 1 deadline on whether to approve Zohydro because the agency needed more time to review information about the drug.
Zogenix officials said they think the FDA is working on "broader, opioid-related issues that need to be addressed prior" to reaching a decision.
Zogenix said the FDA has told them a decision is likely this summer.
If approved, Zohydro would be the first pure hydrocodone medication available in the United States. Zogenix says Zohydro is safer than other hydrocodone medications because it doesn't contain acetaminophen, which has been proven to cause liver injuries if used long-term.
An FDA advisory panel of experts in December voted 11-2 against approval of Zohydro over concerns about potential abuse.