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# FDA Accepts NDA for Sublingual Form of ALS Drug
- URL: https://www.fdaweb.com/fda-accepts-nda-for-sublingual-form-of-als-drug/
- Published: 2018-11-26T12:00:00.000Z
- Updated: 2026-09-15T00:46:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142891

FDA has accepted for review a Biohaven Pharmaceutical Holding Co. 505(b)(2) NDA for BHV-0223, an investigational sublingual form of riluzole for treating patients with amyotrophic lateral sclerosis (ALS). Biohaven previously announced that the agency granted orphan drug designation for BHV-0223 in ALS. The company says BHV-0223 is a novel, lower dose formulation of riluzole, which is the only FDA-approved treatment to extend tracheostomy-free survival in people living with ALS.

The submission is supported by data from multiple studies and clinical trials evaluating the bioequivalence of BHV-0223 to riluzole oral tablets (Rilutek), as well as the safety and tolerability of BHV-0223\. Data showed that sublingual administration of BHV-0223 (40 mg) achieved similar blood exposures to orally ingested Rilutek (50 mg), the company says.