Hysingla ER is an extended-release hydrocodone tablet that’s difficult to crush, break or dissolve, and therefore, harder to snort or inject. The approval comes at a time that prescription opioid abuse has reached epidemic levels in Oregon and across the U.S.
Dr. David Russo, a pain management specialist with Columbia Pain Management P.C. in Hood River, said the pill is a step in the right direction.
“We need many tools in our arsenal to make access to pain management safe and effective,” Russo said. “While the science of abuse deterrents is new and evolving, I’m happy the FDA has taken proactive steps.”
Another pain specialist, Dr. Paul Coelho in Corvallis, was less enthusiastic.
“While I appreciate the abuse deterrence, I feel that we just do not need more hydrocodone products released and marketed at this time,” he said.
He noted that the drug’s manufacturer, Purdue Pharma, has a “history of aggressive marketing. We will see it with this product as well,” he said in an email.
Dr. Andrew Mendenhall, medical director of Hazelden at Beaverton, said Hysingla may be harder to crush, but it isn’t “intrinsically less reinforcing” than regular hydrocodone.
“I think it’s well intentioned in terms of pharma coming up with medications that are harder for individuals to abuse,” Mendenhall said.
But the fact remains, he said, that there’s no evidence that long-term use of opioid therapy is helpful for chronic, noncancer pain management.
“The foundation of the development of addiction is the idea of reinforcement — does it feel good when you start using it every day?,” Mendenhall said.
Hysingla is the second extended-release pure hydrocodone drug approved in the past year or so. The first was Zohydro, which the FDA approved against the advice of its own advisory committee. The agency required Purdue to conduct post-marketing studies of Hysingla to assess the efficacy of its abuse-deterrent features.
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