GUIDANCE DOCUMENT
Migraine: Developing Drugs for Preventive Treatment June 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2022-D-1729
- Docket Number:
- FDA-2022-D-1729
- Issued by:
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the preventive treatment of migraine. Pharmacological approaches to the treatment of migraine include drugs to abort migraine attacks as they arise (acute treatment of migraine) and drugs to reduce the frequency of migraine attacks (preventive treatment). Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs to support approval of drugs for the preventive treatment of migraine. This guidance does not address the development of drugs indicated for the acute treatment of migraine. Such development has been addressed in the guidance for industry Migraine: Developing Drugs for Acute Treatment (February 2018).