NIH Outlines New Game Plan to Combat Opioid Crisis

Megan Brooks

June 13, 2018

The National Institutes of Health (NIH) has outlined its strategy to combat the opioid addiction crisis and improve pain management.

"Extraordinary focus by all segments of society is required to respond to the nation's opioid crisis. Now is the time to channel the efforts of the scientific community to deliver effective — and sustainable — solutions to this formidable public health challenge," write NIH Director Francis Collins, MD, PhD, along with Walter Koroshetz, MD, director of the National Institute of Neurological Disorders and Stroke, and Nora Volkow, MD, director of the National Institute on Drug Abuse.

Congress added $500 million to the base appropriation of the NIH, beginning in fiscal year 2018. "The NIH will invest these much-needed resources to support science that advances national priorities for addiction and pain research, with a bold new trans-NIH initiative called Helping to End Addiction Long-term (HEAL)," Collins, Koroshetz, and Volkow write. 

The plan was outlined in an article published online June 12 in JAMA.

Pioneering Initiative

"Like most other pioneering scientific initiatives, HEAL will focus on a range of objectives, from short-term goals to research priorities that will take longer to bear fruit. Yet, all will be aimed at the same ultimate vision: a nation of people with far less disabling pain and opioid addiction," they say.

The HEAL initiative will focus on two main areas: improving treatments for patients who misuse or are addicted to opioids and enhancing strategies for pain management.

Methadone, buprenorphine, and naltrexone are effective for opioid use disorder (OUD), but only a small percentage of people in the United States who would benefit receive these medications, Collins and coauthors point out. Even among those who start these medications, about half will relapse within 6 months.  Research is needed to reformulate these medications to improve adherence, as well as to develop new, more flexible therapies for people with OUD. 

Similarly, although the opioid antagonist naloxone can effectively reverse opioid overdose, its relatively short half-life compared with those of synthetic opioids (fentanyl and its analogues) often necessitates multiple doses to reverse respiratory arrest, and its effectiveness declines when opioids are combined with other drugs, such as alcohol and benzodiazepines, the authors say.

"HEAL will catalyze the development of extended-release formulations of existing medications to treat OUD, longer-acting formulations of opioid antagonists or partial agonists, new therapies to counter opioid-induced respiratory depression, and novel medications and immunotherapies to treat OUD and prevent and reverse overdoses," they write.

Ending addiction long-term will also require finding new ways to effectively manage acute and chronic pain, they note. Therefore, the second major focus of the HEAL research plan includes a "coordinated approach to discover and validate new biologic targets for effective, nonaddictive pain management, as well as accelerate the process of discovery to develop therapies aimed at these targets," Collins and coauthors say.

HEAL lays the foundation for an innovative therapy-development pipeline through a planned new public-private partnership, they note.

The NIH will collaborate with biopharmaceutical groups, the US Food and Drug Administration, and the Foundation for the NIH to collect and evaluate treatment assets from academia and biopharmaceutical and device companies to coordinate and accelerate the development of effective treatments for pain and addiction. The most promising assets will be tested in HEAL's clinical trial networks, which will focus primarily on phase 2 trials.

The authors have disclosed no relevant financial relationships.

JAMA. Published online June 12, 2018. Full text

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