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Biohaven’s epilepsy drug hit with FDA clinical hold
Biohaven has paused pivotal study enrolment while the company characterises a metabolite of opakalim and its safety in humans. Pivotal study enrolment has been paused while Biohaven characterises a metabolite of opakalim and its safety in humans. Opakalim is currently in development for the treatment of focal onset seizures. Credit: Berit Kessler / Shutterstock.com. The US Food and Drug Administration (FDA) has placed a partial clinical hold on the pivotal trials evaluating Biohaven’s epilepsy candidate, opakalim, following safety signals found during comprehensive metabolite characterisation in the company’s nonclinical testing. In an 8-K form, Biohaven detailed its communications with global regulators,…
Biohaven has paused pivotal study enrolment while the company characterises a metabolite of opakalim and its safety in humans.
Source: Clinical Trials Arena