Abuse-Deterrent Opioids: What You Need to Know

Lauri R. Graham; Laurie Scudder, DNP, NP; Douglas Throckmorton, MD

Disclosures

August 25, 2016

Editorial Collaboration

Medscape &

A Work in Progress

Medscape: Besides supporting the development of abuse-deterrent products, can you briefly describe the other strategies that the FDA is exploring to address the opioid epidemic that may be helpful to clinicians?

Dr Throckmorton: In February of this year, Commissioner Robert Califf (then the FDA's Deputy Commissioner for Medical Products and Tobacco) announced the FDA Opioids Action Plan. The plan focuses on policies aimed at reversing the opioid epidemic, while still providing patients in pain access to effective pain relief.

The FDA actions include:

  • Convening an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties;

  • Consulting with the Pediatric Advisory Committee (meeting scheduled for this September) about a framework for pediatric opioid labeling before any new labeling is approved;

  • Updating the REMS requirements for ER/LA opioid analgesics after considering the advisory committee's recommendations from a meeting held in May 2016 and reviewing existing requirements;

  • Improve access to naloxone (by facilitating the development of an over-the-counter version of naloxone, which is currently only available by prescription, making naloxone more accessible to treat opioid overdose), and medication-assisted treatment options for patients with opioid use disorders; and

  • Support better pain management options, including alternative, nonaddictive treatments for pain. For example, the FDA is conducting research on pain measurements for such conditions as chronic low back pain, osteoarthritis, diabetic neuropathy, postherpetic neuralgia, and fibromyalgia. The FDA is also working to support the development of nonopioid options for these patients.

Consistent with the plan, in March 2016, the FDA announced that it was requiring changes to the labeling on immediate-release opioids, including additional warnings and safety information that are expected to incorporate elements similar to the ER/LA opioid analgesics labeling that is currently approved.

Furthermore, among other steps, the FDA has contracted with the National Academy of Medicine to provide us with advice on how we should incorporate current evidence about the public health impact of opioid use (for patients who are prescribed opioids, as well as for nonpatients) into regulatory activities concerning opioids. We look forward to the recommendations from the academy, with a report expected in 2017, and other experts to further inform our policies in this area.

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