FDA Places Partial Clinical Hold on Biohaven's Pivotal Trials for Epilepsy Candidate Opakalim

The U.S. Food and Drug Administration (FDA) has issued a partial clinical hold on pivotal trials for Biohaven's epilepsy drug candidate, opakalim. The hold follows safety signals identified during nonclinical testing, specifically concerning insufficient information about a specific metabolite's risk to humans. New patient enrollment is paused, but existing patients can continue dosing.