
[Federal Register Volume 77, Number 105 (Thursday, May 31, 2012)]
[Notices]
[Pages 32124-32125]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13143]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0146]


Guidance for Industry on Irritable Bowel Syndrome--Clinical 
Evaluation of Drugs for Treatment; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Irritable Bowel 
Syndrome--Clinical Evaluation of Drugs for Treatment.'' This guidance 
is intended to assist the pharmaceutical industry and investigators who 
are developing drugs for the treatment of irritable bowel syndrome 
(IBS), specifically the IBS indications for IBS with diarrhea (IBS-D) 
and IBS with constipation (IBS-C). The guidance describes the evolution 
of patient-reported outcome (PRO) measures as primary endpoints for IBS 
clinical trials, and sets forth provisional endpoints and trial design 
recommendations that sponsors may apply to IBS clinical trials as PRO 
measurements continue to evolve. The guidance also discusses the future 
development of IBS PRO instruments. This guidance finalizes the draft 
guidance published in March 2010.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: 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, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, 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 
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ruyi He, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 5122, Silver Spring, MD 20993-0002, 301-796-0910.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Irritable Bowel Syndrome--Clinical Evaluation of Drugs for 
Treatment.'' This guidance is intended to assist the pharmaceutical 
industry and investigators who are developing drugs for the treatment 
of IBS. This guidance applies to the IBS indications for IBS-D and IBS-
C.
    A well-defined and reliable PRO instrument that measures the 
clinically important signs and symptoms associated with each IBS 
subtype would be the ideal primary efficacy assessment tool in clinical 
trials used to support labeling claims, but at this time such an 
instrument is not available. We recognize that it will take some time 
to develop adequate instruments and that in the meantime there is a 
great need to develop effective therapies for patients with IBS. 
Therefore, until the appropriate PRO instruments have been developed, 
sponsors should consider the provisional endpoints and trial design 
recommendations set forth in the guidance.
    This guidance was published as a draft guidance in March 2010. 
Changes made to the guidance took into consideration written and verbal 
comments received. In addition to editorial changes primarily for 
clarification, the major changes are as follows:
     The section on trial design was modified by adding a 
randomized withdrawal design to address the need for maintenance 
treatment to prevent sign or symptom recurrence.
     The section on trial endpoints was modified to note that a 
drug can be specifically developed to treat only one of two major signs 
or symptoms of IBS (abnormal defecation or abdominal pain). 
Demonstration of significant and clinically meaningful changes in the 
targeted single endpoint could serve as a basis for approval, as long 
as the other important symptom or sign has not worsened on treatment.
     Trial entry criteria for IBS-D were modified to allow more 
IBS-D patients to participate in IBS clinical trials, and the 
definition of a responder to treatments for IBS-D was modified 
accordingly.
     Definitions of a responder for abdominal pain alone, 
constipation, and diarrhea were added.

[[Page 32125]]

     The use of a daily responder analysis for IBS-D as a 
primary analysis was included.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on the clinical evaluation of drugs for the 
treatment of IBS. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: May 23, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-13143 Filed 5-30-12; 8:45 am]
BILLING CODE 4160-01-P


