New Research Guidance from the FDA
‘Migraine: Developing Drugs for the Acute Treatment – Guidance for Industry’ offers insights on clinical trial design.
On February 15, 2018 the FDA issued 5 new guidance documents designed to accelerate the development and advancement of novel treatments for neurological diseases. One of those is focused on Developing Drugs for the Acute Treatment of Migraine.
AHS leadership worked with FDA to inform the 2018 version; which is a finalization of the draft guidance that was issued in 2014. Approval of drugs for the acute treatment of migraine was based on the demonstration of an effect on four co-primary endpoints: pain, nausea, photophobia and phonophobia. And, while this approach remains acceptable, FDA now cites a preferred approach which includes a demonstration of effect on pain as well as the patient’s most-bothersome symptom.
Here is a link to both the draft guidance as well as the accompanying FDA statement. Of note; FDA states that additional disease-specific guidance is expected later this year; including those for treatments for opioid dependence and addiction.
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