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# Non-Opioid Analgesic Development Guidance
- URL: https://www.fdaweb.com/non-opioid-analgesic-development-guidance/
- Published: 2025-09-10T12:00:00.000Z
- Updated: 2026-09-14T15:21:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159840

FDA has issued a draft guidance, *Development of Non-Opioid Analgesics for Chronic Pain*, to assist sponsors in developing such drugs. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-non-opioid-analgesics-chronic-pain?ref=fdaweb.com) says it is intended to address two agency priorities — fostering the development of novel analgesic products, and decreasing opioid analgesic exposure and preventing new addiction.

The guidance describes the agency’s current recommendations on Phase 3 trials for prescription non-opioid analgesic products being developed to treat chronic pain. It does not provide general recommendations on early phases of non-opioid analgesic drug development. It also does not have specific recommendations on pediatric drug development, and does not address the development of drugs to treat acute pain.

In a [statement](https://content.govdelivery.com/accounts/USFDA/bulletins/3f1f523?ref=fdaweb.com), FDA commissioner **Martin Makary** says, “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. 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.”

The statement says the draft outlines regulatory considerations related to:

- establishing indications for different scopes (e.g., broader categories covering multiple chronic pain conditions versus individual chronic pain indications);
- designing clinical trials that ensure robust evaluation of safety and efficacy, including innovative trial designs and the role of mechanistic understanding of both the drug and the chronic pain conditions being treated;
- evaluating the ability of non-opioid drugs to avoid, reduce, or eliminate opioid use; and
- incorporating statistical principles, patient-reported outcomes, and the use of expedited programs to support drug development in this area.