FDA Issues New Guidance to Accelerate Development of Safe, Effective Nonopioid Pain Treatments
As part of the guidance, the FDA emphasizes drug development, specifically with trial design, patient populations, and outcomes such as reducing the need for opioids.
The FDA issued a new guidance to accelerate the development and approval of safe and effective nonopioid treatments, reducing opioid prescription misuse. As part of the guidance, the FDA emphasizes drug development, specifically with trial design, patient populations, and outcomes such as reducing the need for opioids.1
As part of the guidance, the FDA emphasizes drug development, specifically with trial design, patient populations, and outcomes such as reducing the need for opioids. | Image Credit: Zerbor - stock.adobe.com
“America’s opioid crisis is not over. We must stay vigilant to address this longstanding problem in new ways. Physicians need more alternatives to opioid medications for patients suffering from chronic pain,” Marty Makary, MD, MPH, commissioner of the FDA, said in a news release.1 “FDA can help by providing clear guidance like this, which makes regulatory pathways more predictable for innovators and drug developers, enabling effective, lower-risk therapies to quickly reach the millions of Americans living with chronic pain.”
Approximately 105,000 people died from a drug overdose in 2023, and about 76% of deaths involved opioids, according to the CDC. Additionally, the number of patients who died due to an opioid drug overdose in 2023 was nearly 10 times the number in 1999. The rate of overdose deaths with synthetic opioids other than methadone decreased by 1%, overdose deaths involving heroin decreased by 33%, and overdose deaths involving prescription opioids decreased by nearly 12%.2
The draft guidance includes considerations for indications for different scopes, including broader categories to cover multiple chronic pain conditions compared with individual indications; clinical trial designs that determine mechanistic understanding of the chronic condition and the drug; the ability of nonopioid drugs to avoid, reduce, or eliminate opioid use; and the use of statistical principles, patient-reported outcomes, and expedited programs.1
The guidance is part of a larger FDA strategy to address the opioid crisis, which also includes safety label changes for opioid pain medications to reflect current evidence, enhanced enforcement for importation, and development of nonopioid drugs.1
In 2025, the FDA approved the first and only nonopioid analgesic, suzetrigine (Journavx), which is used to treat moderate to severe acute pain in adults. The approval marks the first-in-class pain management medication, which is targeting nonopioid pain management.3
“I think the important thing to remember with suzetrigine right now is that it has been studied in and is indicated for acute [pain], and so certainly it has the potential to reduce the use of opioids perioperatively, which is how it was studied,” Madison Irwin, PharmD, BCPS, a clinical pharmacist specialist in palliative care at the University of Michigan Health and a clinical assistant professor at the University of Michigan College of Pharmacy, said.3 “It remains to be seen what its place is going to be in the chronic pain space.”
Suzetrigine was evaluated in 2 randomized, double-blinded trials for acute surgical pain, with one for abdominoplasty and the other for bunionectomy. The highest dose of the drug reduced acute pain for over 48 hours for both procedures. Pharmacists can play a large role in substance use disorder for patients. Because of their accessibility in health care, pharmacists are able to screen for diversion, monitor opioid use disorder, and educate patients on opioid-related risks.3
“Our health care system is so very complicated that one should take pause [at] the reality that it’s rather hard to [obtain] a prescription pain medication these days, any of them, beyond OTCs, and if a patient is not actually willing to dispose of their pain medication for fear of having to navigate the system in the future to simply attain pain relief, that’s a real raw reality that must be at least acknowledged,” Mark Garofoli, PharmD, MBA, BCGP, CPE, CTTS, director of experiential learning at West Virginia University School of Pharmacy and clinical pain and addiction pharmacist at West Virginia University Medicine, said.3
READ MORE: Nonopioid Pain Management Resource Center
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REFERENCES
1. FDA issues new guidance to expand non-opioid options for chronic pain, curb misuse. News release. FDA. September 10, 2025. https://www.fda.gov/news-events/press-announcements/fda-issues-new-guidance-expand-non-opioid-options-chronic-pain-curb-misuse
2. CDC. Understanding the opioid overdose epidemic. June 9, 2025. Accessed September 10, 2025. https://www.cdc.gov/overdose-prevention/about/understanding-the-opioid-overdose-epidemic.html
3. Gallagher A. First-in-class drug approval for acute pain highlights need for nonopioid therapies. Drug Topics. April 9, 2025. Accessed September 11, 2025. https://www.drugtopics.com/view/first-in-class-drug-approval-for-acute-pain-highlights-need-for-nonopioid-therapies
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