The US Food and Drug Administration (FDA) on Thursday released a draft guidance to help sponsors develop drugs to prevent migraines that offers recommendations on trial population, trial design, dose selection, efficacy endpoints and statistical considerations.
The agency defines migraines as a “chronic neurovascular disorder characterized by recurrent attacks of often severe headache, typically presenting with nausea, vomiting, and sensitivity to light and/or sound.”
Current pharmacological approaches include treating acute migraine attacks as they arise or reducing the frequency of migraine attacks as a preventive treatment. This guidance addresses preventive treatments; previous guidance addressed drugs for treating acute migraines in 2018. (RELATED: Draft and Final FDA Guidances Detail Development of New Drugs for Neurological Disorders, Regulatory Focus 15 February 2018)
The agency said the guidance “is intended to serve as a focus for continued discussions among FDA’s Division of Neurology II, sponsors, the academic community, and the public.”…
