26 November 2018 - If approved, BHV-0223 would become the only formulation of riluzole that does not require swallowing tablets or liquids, offering an important delivery alternative for the standard-of-care treatment of amyotrophic lateral sclerosis.

Biohaven Pharmaceutical today announced that its 505(b)(2) new drug application for BHV-0223, an investigational sublingual form of riluzole for the treatment of people living with amyotrophic lateral sclerosis (ALS), has been accepted for review by the U.S. FDA. 

Biohaven previously announced that the FDA granted orphan drug designation for BHV-0223 in ALS. BHV-0223 is a novel, lower dose formulation of riluzole designed to be placed under the tongue where it dissolves in seconds and is absorbed sublingually. The active ingredient, riluzole, is the only FDA-approved treatment to extend tracheostomy-free survival in people living with ALS.

Read Biohaven Pharmaceutical press release