Four drugmakers have asked the US Food and Drug Administration (FDA) to amend some of the requirements in its draft guidance on developing migraine prevention medications, including the preference that 70% of a study population to be off all migraine preventives at clinical trial enrollment.
The draft has been open for public comment since it was posted in early June. While no patients or patient advocacy groups filed comments, four drugmakers (Pfizer, AbbVie, Lundbeck and Eli Lilly) did. FDA’s draft requirements on concomitant medications and its separation of chronic and episodic migraine were among their top concerns.
According to the draft guidance, the use of concomitant treatments should be minimized as much as possible in clinical trials of migraine preventives, because they could mask both response and safety signals…
