Biohaven Completes Enrollment in Pivotal Phase 2/3 Focal Epilepsy Study of Opakalim

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Biohaven has completed enrollment in RISE3, a pivotal Phase 2/3 study evaluating its selective Kv7.2/7.3 activator opakalim for refractory focal epilepsy, with top-line results expected in the second half of 2026. The randomized, double-blind, placebo-controlled trial enrolled adults with refractory focal onset seizures who were taking one to three concurrent antiseizure medicines, randomizing them to 75 mg or 50 mg of opakalim or placebo once daily for an eight-week treatment period. In an ongoing open-label extension study, 54% of participants on opakalim 75 mg once daily achieved at least a 50% reduction in seizure frequency over any consecutive six months compared to pre-randomization baseline, with a markedly lower incidence of nervous system adverse events such as 5% dizziness and 4% fatigue. Approximately 95% of participants who reached the end of the double-blind treatment period in the pivotal RISE2 and RISE3 studies completed it, and about 95% of those rolled over into the optional open-label extension, reflecting favorable patient experience.

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Completed enrollment in pivotal Phase 2/3 epilepsy study with positive open-label extension data showing efficacy and tolerability.

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