Biohaven Pharma initiates Phase III trial for Zydis to treat migraine.
-Biohaven Pharmaceutical announced that it has enrolled the first patient in a Phase III 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 III 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 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.
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