Development of Non-Opioid Analgesics for Chronic Pain

Docket Number: FDA-2025-D-0610 Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Development of Non-Opioid Analgesics for Chronic Pain.” This guidance is intended to assist sponsors in the development of non-opioid analgesics for the treatment of chronic pain. It describes FDA’s current recommendations regarding phase 3 trials for prescription non-opioid analgesic products being developed to treat chronic pain. This guidance also responds to the statutory requirements of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, which directs FDA to issue or update existing guidance to help address challenges to developing non-opioid medical products to treat pain.

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Dockets Management
Food and Drug Administration
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All written comments should be identified with this document’s docket number: FDA-2025-D-0610.

• Content current as of:

  09/10/2025

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