Bioequivalence study shows Zydis with rimegepant meets targets in migraine.- Biohaven Pharma.

Biohaven Pharmaceutical announced positive results from its bioequivalence study with Zydis (rimegepant) orally dissolving tablets (ODT), currently in two pivotal Phase III trials for the acute treatment of migraine using a tablet formulation. The purpose of the bioequivalence study was to demonstrate pharmacokinetic equivalence of the rimegepant Zydis ODT formulation compared to the rimegepant tablet formulation used in the Phase III program.

Topline results demonstrate that the Zydis ODT achieves bioequivalent exposures relative to the current Phase III tablet fomulation. In the study, 34 healthy volunteers were administered rimegepant 75mg Zydis ODT and the current rimegepant 75mg tablet. In the pre-specified primary analysis, rimegepant Zydis ODT achieved area-under-the-curve and peak exposures of approximately 97% and 105%, respectively, compared to those generated by rimegepant tablet. The 90% confidence intervals were within the 80% to 125% range that is commonly used to define bioequivalence.

Based upon these bioequivalence results, Biohaven is planning to initiate a Phase III trial with Zydis ODT in the first quarter of 2018 to assess onset of action and patient satisfaction with the Zydis ODT formulation. Biohaven's development program enables the potential to bring rimegepant to market with this new formulation while staying on track with its original rimegepant development timeline. Biohaven expects to receive topline results from its two pivotal Phase III trials examining the efficacy of rimegepant 75mg oral tablet versus placebo in the acute treatment of migraine by the end of the first quarter of 2018.