Biohaven has enrolled the first patient in a Phase 3 clinical trial of the Zydis orally dissolving tablet (ODT) formulation of rimegepant for the acute treatment of migraine. Rimegepant is a potent, orally available small molecule calcitonin gene-related peptide (CGRP) receptor antagonist in late stage development for the treatment of migraine.
The Phase 3 clinical trial will assess the onset of action, patient satisfaction, efficacy and safety of the fast-dissolve Zydis ODT formulation of rimegepant. Biohaven has been working with Catalent U.K. Swindon Zydis Limited, a subsidiary of Catalent, Inc. to develop this new ODT formulation of rimegepant and extend additional delivery formulations across its CGRP platform. Biohaven has entered into an exclusive agreement with Catalent for the use of the Zydis ODT formulation technology in the development of small molecule CGRP receptor antagonists. The trial will randomize approximately 850 patients across two treatment arms, rimegepant 75 mg ODT versus placebo.
"Biohaven is committed to bringing the most differentiated oral, small molecule CGRP receptor antagonist to patients suffering from migraine. The fast-dissolving Zydis ODT rimegepant formulation is designed to conveniently enable people experiencing a migraine attack to promptly initiate their acute treatment without the need for taking with liquids. We believe that rimegepant Zydis ODT has the potential to be a best-in-class therapy option for the acute treatment of migraine," Vlad Coric, M.D., Chief Executive Officer at Biohaven, said.
Biohaven continues to expect topline results from its two pivotal Phase 3 trials examining the efficacy of rimegepant 75 mg oral tablet versus placebo by the end of the first quarter of 2018, and expects topline results from the Phase 3 trial with rimegepant Zydis ODT in the fourth quarter of 2018.