First Patient Enrolled in Phase 3 Clinical Trial of Rimegepant for Acute Migraine Treatment
Biohaven Pharmaceutical (New Haven, CT) announced today the first patient enrollment in their phase 3 clinical trial of rimegepant (Zydis) for the acute treatment of migraine. Zydis is an orally dissolving tablet formulation of rimegepant, a potent small molecule calcitonin gene-related peptide receptor (CGRP) antagonist. Biohaven has been working with Catalent (Somerset, NJ) to develop new formulations of rimegepant, extending delivery options for CGRP antagonists. Biohaven has entered into an exclusive agreement with Catalent for the use of the orally dissolving formulation in the development of small molecule CGRP receptor antagonists.
The phase 3 clinical trial aims to enroll 850 subjects in two groups, one treated with 75 mg of oral rimegepant and the other given placebo, to assess safety, efficacy, onset of action, and patient satisfaction for the fast-dissolve oral formulation of rimegepant.
Vlad Coric, M.D., Chief Executive Officer at Biohaven, said " 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."
Biohaven expects topline results from its 2 pivotal phase 3 trials examining rimegepant 75 mg oral tablet efficacy versus placebo by the end of March, 2018 and topline results from the phase 3 trial with rimegepant Zydis® ODT by the end of 2018.