The Food and Drug Administration has paused new patient enrollment in trials of opakalim, an experimental epilepsy drug also known as BHV-7000, over questions raised in rodent studies. Biohaven disclosed in a filing with the U.S. Securities and Exchange Commission that the FDA issued a partial clinical hold letter on Sept. 4.
According to the filing, there was not enough information about a specific metabolite, a substance produced when the body breaks down a drug, to assess its risk to people. Dosing continues for the more than 600 patients already randomized, or assigned to a study group, across the program. No new patients can join until additional animal studies are completed.
