Issue Date: February 16, 2018
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Final
Migraine: Developing Drugs for Acute Treatment
The purpose of this guidance is to assist sponsors in the clinical development of prescription drugs for the acute treatment of migraine. Specifically, this guidance addresses FDA’s current thinking regarding the overall development program and clinical trial designs to support approval of prescription drugs for the acute treatment of migraine.3 This guidance does not apply to overthe-counter drug products. This guidance also does not address the development of drugs indicated to reduce the frequency of migraine attacks. Such development will be addressed separately in a future guidance.
Download the Guidance Document
