Notice2025-17442
Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry; Availability
Primary source
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Published
September 11, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Development of Non-Opioid Analgesics for Chronic Pain."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.
Full Text
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<title>Federal Register, Volume 90 Issue 174 (Thursday, September 11, 2025)</title>
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[Federal Register Volume 90, Number 174 (Thursday, September 11, 2025)]
[Notices]
[Pages 44074-44075]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-17442]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-D-0610]
Development of Non-Opioid Analgesics for Chronic Pain, Draft
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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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the availability of a draft guidance for industry entitled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.
DATES: Submit either electronic or written comments on the draft
guidance by November 10, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2025-D-0610 for ``Development of Non-Opioid Analgesics for Chronic
Pain.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Matthew Sullivan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993, 301-796-1245.
SUPPLEMENTARY INFORMATION:
I. Background
FDA 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 section 3001(b)
of the SUPPORT Act (Pub. L. 115-271), which directs FDA to issue or
update existing guidance to help address challenges to developing non-
opioid medical products to treat pain.
This guidance does not address the development of drugs for the
treatment of acute pain, which is the subject of a separate guidance;
\1\ local anesthetic drug products with prolonged duration of effect,
which is also the subject of a
[[Page 44075]]
separate guidance; \2\ or opioid or opioid-containing analgesic
products.
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\1\ See the draft guidance for industry ``Development of Non-
Opioid Analgesics for Acute Pain,'' available at <a href="https://www.fda.gov/media/156063/download">https://www.fda.gov/media/156063/download</a>.
\2\ See the draft guidance for industry ``Development of Local
Anesthetic Drug Products With Prolonged Duration of Effect,''
available at <a href="https://www.fda.gov/media/166210/download">https://www.fda.gov/media/166210/download</a>.
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This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Development
of Non-Opioid Analgesics for Chronic Pain.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. As we develop any final guidance
on this topic, FDA will consider comments on the applicability of
Executive Order 14192, per OMB guidance M-25-20, and in particular, on
any costs or cost savings.
II. Supplementary Information on Comment Submissions
In addition to the instructions on submitting electronic or written
comments provided above, FDA is providing suggestions for organizing
comments to help facilitate FDA's review and analysis.
It is helpful to distinguish comments that are general in nature
from comments that pertain to a specific section or specific text in
the guidance. Note that each line of text in the guidance is numbered.
If your comments pertain to a particular section or line number of the
guidance, please include the section and/or line number(s) with your
comment. Following is an example format that could be used to organize
comments. Note that use of this format is optional.
The following is an example comment format (with example text and
instructions italicized):
1. General Comments
[Include general comment]
[Include general comment]
2. Specific Comments on Text
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Document section Line No. Comment
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I. Introduction............... Lines 27-30...... [Include comment,
rationale, and
proposed changes (if
any)].
I. Introduction............... Lines 39-42...... [Include comment,
rationale, and
proposed changes (if
any)].
II. Background................ Line 80.......... [Include comment,
rationale, and
proposed changes (if
any)].
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III. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521).
The collections of information in 21 CFR parts 50 and 56 for
protection of human subjects and institutional review boards have been
approved under OMB control number 0910-0130. The collections of
information in 21 CFR 58 for good laboratory practice have been
approved under OMB control number 0910-0119. The collections of
information in 21 CFR 210 and 211 for current good manufacturing
practice have been approved under OMB control number 0910-0139. The
collections of information in 21 CFR part 312 for investigational new
drug applications, conducting clinical trials, good clinical practice,
and collecting data for such trials have been approved under OMB
control number 0910-0014. The collections of information in 21 CFR part
314 for new drug applications and abbreviated new drug applications
trials have been approved under OMB control number 0910-0001. The
collections of information in 21 CFR 201.56 and 201.57 regarding
content and format requirements for labeling for human prescription
drug and biological products have been approved under OMB control
number 0910-0572. The collections of information in 21 CFR parts 601
and 610 for biologics license applications have been approved under OMB
control number 0910-0338. The collections of information in 21 CFR part
11 regarding electronic records and signatures have been approved under
OMB control number 0910-0303. The collections of information for
expedited pathways for development programs of drugs and biologics for
serious conditions have been approved under OMB control number 0910-
0765.
IV. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-17442 Filed 9-10-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on September 11, 2025.
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