Description
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Development of Non-Opioid Analgesics for Chronic Pain.”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.
Scope & Applicability
Product Classes
3Development of non-opioid analgesics for the treatment of chronic pain.; facilitating development of non-opioid analgesics can help address the need for more analgesic treatment options; Development of non-opioid analgesics for chronic pain
FDA remains interested in feedback on ways in which these data could be useful to support the approval of non-opioid analgesic products.
products being developed for chronic pain
Stakeholders
2Entity responsible for submitting applications under section 524B
population that should not be routinely excluded from trials
Regulatory Context
Attributes
4How the product achieves its intended purpose.
indication reflecting drug action on a mechanism shared across pain conditions
broadest indication reflecting effectiveness for all chronic pain conditions
confidence that the active control provides the expected extent of analgesic effect
Identified Hazards
Hazards
2clinical development program must also establish the safety of the product... including a thorough assessment of abuse and misuse potential
Risk during down-titration of opioid regimen
Related CFR Sections (3)
- 21CFR314.500§ 314.500 Scope.
This subpart applies to certain new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intoRead full regulation →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
- 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →
See Also (8)
- Product Development Under the Animal Rule (Status: Final)
- Special Protocol Assessment Guidance for Industry (Status: Final)
- Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment (Status: Draft)
- Development of Non-Opioid Analgesics for Acute Pain; Draft Guidance for Industry: Draft Guidance for Industry (Status: Draft)
- Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics (Status: Draft)
- Format and Content of the Clinical and Statistical Sections of an Application (Status: Final)
- Assessment of Abuse Potential of Drugs (Status: Final)
- Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format: Guidance for Industry (Status: Final)