Biohaven announced that the Food and Drug Administration (FDA) has granted orphan drug designation to its Amyotrophic Lateral Sclerosis (ALS) treatment candidate, BHV-0223.

BHV-0223 is a novel formulation of a glutamate-modulating agent. It is a sublingually absorbed and oral dissolving tablet (ODT) formulation of riluzole. Since BHV-0223 is absorbed through the oral mucosa, the company believes it has the potential to bypass first-pass metabolism and deliver effective doses of the drug at lower concentrations. It would also eliminate the need for three hour fasting twice daily and any difficulties patients with problems swallowing may experience with the tablet form. 

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“As a sublingually administered and orally dissolving tablet form of riluzole, we believe that BHV-0233 may offer important advantages to ALS patients,” said Robert Berman, MD, CMO of Biohaven.

Biohaven is pursuing the use of glutamate-modulating agents across several therapeutic indications.  

“If approved, this unique formulation will provide another therapeutic option to patients living with this devastating disease,” said Vlad Coric, MD, CEO of Biohaven.

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