New FDA Guidance Seeks to Expand Nonopioid Options
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Posted On: 09/12/2025 2:51:09 PM
New FDA Guidance Seeks to Expand Nonopioid Options to Manage Chronic Pain and Curb Misuse
September 12, 2025
By Grace Halsey
FDA Commissioner Marty Makary, MD, MPH, emphasized the continued urgency of the opioid crisis, stating that "physicians need more alternatives to opioid medications for people suffering from chronic pain." Despite recent declines in opioid prescribing, approximately 1 in 5 US adults living with chronic pain still receive opioid prescriptions due to limited effective alternatives, the agency stated. While the development of opioid misuse is not universal among those treated long-term with the analgesics, the CDC estimates the rate of opioid misuse to be between 8% and 12%.2
"America's opioid crisis is not over. We must stay vigilant to address this longstanding problem in new ways," Makary noted. "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."
https://www.patientcareonline.com/view/new-fd...urb-misuse
September 12, 2025
By Grace Halsey
FDA Commissioner Marty Makary, MD, MPH, emphasized the continued urgency of the opioid crisis, stating that "physicians need more alternatives to opioid medications for people suffering from chronic pain." Despite recent declines in opioid prescribing, approximately 1 in 5 US adults living with chronic pain still receive opioid prescriptions due to limited effective alternatives, the agency stated. While the development of opioid misuse is not universal among those treated long-term with the analgesics, the CDC estimates the rate of opioid misuse to be between 8% and 12%.2
"America's opioid crisis is not over. We must stay vigilant to address this longstanding problem in new ways," Makary noted. "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."
https://www.patientcareonline.com/view/new-fd...urb-misuse
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