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Biohaven Announces Expedited Development Path for BHV-0223 Following Successful pre-IND Interaction with FDA

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Additional Relevant Details BHV-0223 is a unique formulation of riluzole, a glutamate modulating agent, that utilizes the Zydis ODT fast-dissolve technology under an exclusive worldwide agreement with Catalent. Agents that modulate glutamate neurotransmission may have therapeutic potential in multiple disease states involving glutamate dysfunction, including ALS, Alzheimer's disease, Rett syndrome, dementia, dystonia, tinnitus, anxiety disorders, and affective disorders like major depressive disorder. Biohaven is pursuing the use of glutamate modulating agents across several therapeutic indications.The formal correspondence received from the FDA discussed clinical, nonclinical, and regulatory issues for BHV-0223, including the IND-opening clinical trial design and a proposed development plan for ALS. No issues were identified in the FDA response that would impede Biohaven's planned bioequivalence trial in 2016. The key highlights from the PIND meeting feedback include:
  • The FDA agreed that the 505(b)2 pathway is acceptable for BHV-0223 in ALS.
  • The FDA agreed that no additional efficacy or toxicology studies are necessary for submission of the NDA.

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Occurred on:
Feb 25, 2016
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Related Keywords Zydis, Als, Alzheimer's Disease, Bhv-0223, Rett Syndrome, Dementia, Dystonia, Tinnitus, Anxiety Disorders, Catalent, Glutamate Modulating Agent, Riluzole