FDA ratchets up requirements on long-acting, extended-release opioids

The FDA, under pressure to help curb abuse of opioid painkillers, has taken yet another step to dampen their use. The agency said today that it is "invoking its authority" to require that long-acting and extended-release drugs should only be used for severe pain and only when other measures don't work.

"The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities," said FDA Commissioner Margaret Hamburg. "Today's action demonstrates the FDA's resolve to reduce the serious risks of long-acting and extended release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain."

The agency said the the new labeling will indicate the drugs should only be used when pain management requires daily, around-the-clock, long-term opioid treatment. The FDA said it is also requiring drugmakers to undertake further studies and clinical trials to evaluate the "risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose and death."

The agency has been looking for ways to address the drug abuse problem, even as some members of Congress have considered introducing legislation that would limit opioid use. In April, the FDA took the unusual step of banning any generics of the original long-acting formulation of the best-known drug in the category, OxyContin. It said the danger of abuse outweighed the benefits of a cheaper version of the product. It also, for the first time, gave OxyContin maker Purdue Pharma the right to put a specific claim on its new version of the drug that it is abuse-deterrent.

The agency is encouraging pain drugmakers to develop new tamper-resistant drugs. It also in July approved Zubsolv, a drug from Swedish drug developer Orexo for treating opioid addiction, a problem that the company says affects nearly 5 million people in the U.S. and leads to about 17,000 deaths annually.

- here's the FDA announcement

Related Articles:
FDA halts generic OxyContin, handing Purdue a victory
FDA hearing on opioids reflects evolving view on painkiller use
FDA taking on pain drugs' knotty issues
Orexo gets FDA approval for opioid addiction-fighting Zubsolv
FDA panel painkiller decision leads toward new approach

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