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ODT Formulation in Development for Migraine Treatment

Phase 3 clinical trial of Zydis set to launch

A PPM Brief

The first patient has been enrolled in a Phase 3 clinical trial of Zydis, an orally dissolving tablet (ODT) formulation of rimegepant for the acute treatment of migraine, announced developers Biohaven Pharmaceuticals (New Haven, CT).1 The trial will randomize approximately 850 patients across two treatment arms: rimegepant ODT (75 mg) versus placebo. The trial will assess the onset of action, patient satisfaction, efficacy and safety of the rimegepant ODT formulation.

Rimegepant is a potent, orally available small molecule calcitonin gene-related peptide (CGRP) receptor antagonist that is currently in late-stage development for the treatment of migraine. According to the company release, Biohaven expects topline results from its two Phase 3 trials examining its efficacy by the end of the first quarter of 2018, and topline results in the fourth quarter of this year.1

CGRP receptor antagonists are being highly watched and have been in development by a number of companies as migraine treatments evolve. These new class of inhibitors has been well tolerated in short-term studies, but long-term adverse effects remain unknown.

“This clinical trial with the new fast-dissolve Zydis ODT formulation complements our ongoing work with rimegepant,” said Robert Croop, MD, chief development officer of neurology at Biohaven, in the release. “We are very pleased to incorporate the trial into our ongoing Phase 3 clinical program.”

In developing this new ODT formulation of rimegepant and extending additional delivery formulations across its CGRP platform, Biohaven has partnered with a subsidiary of Catalent, Inc. (Swindon, England, UK), entering into an exclusive agreement for the use of the Zydis ODT formulation technology in the development of small molecule CGRP receptor antagonists.1

Update 11/15/18: Biohaven has announced that the first patient has been enrolled in its Phase 3 trial of preventive migraine treatment with rimegepant, where topline data is expected in 2019.

Update 7/11/19: In a July 2019 study, treatment of a migraine attack with rimegepant resulted in a higher percentage of patients who were free of pain 2 hours after receiving a dose of 75mg and free from their most bothersome symptom than placebo.

Last updated on: August 13, 2019
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