💊FDA Releases Guidance on Non-Opioid Analgesics for Chronic Pain
Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Development of Non-Opioid Analgesics for Chronic Pain."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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's draft guidance for developing non-opioid analgesics directly impacts businesses in the pharmaceutical industry, as it sets compliance recommendations for phase 3 trials vital for market entry. Compliance with the SUPPORT Act requirements emphasizes the need for innovation in pain management and potential financial implications in developing these products.