Biohaven Pharmaceuticals has won an orphan drug designation from the FDA for the company’s drug candidate BHV-0223, an orally dissolving tablet being developed for the treatment of Amyotrophic Lateral Sclerosis (ALS), also referred to as Lou Gehrig’s disease.

This is the Company’s third orphan drug designation request granted by the FDA.

BHV-0223 is a sublingually absorbed and oral dissolving tablet formulation of riluzole. BHV-0223’s novel formulation is designed to address some of the shortcomings associated with the solid oral dosage form of riluzole that ALS patients have difficulty swallowing. ​