Biohaven Announces FDA Acceptance of 505(b)(2) NDA Filing for BHV-0223, a Novel Sublingual Delivery Form of Riluzole for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

ALS is a progressive neurodegenerative motor neuron disease affecting nerve cells in the brain and the spinal cord in which patients experience muscle weakness, trouble swallowing and muscle atrophy that ultimately progresses to paralysis, impaired breathing and death. More than 80% of people living with ALS experience dysphagia, which is difficulty swallowing, during their disease course.

The 505(b)(2) NDA submission is supported by data from multiple studies and clinical trials evaluating the bioequivalence of BHV-0223 to riluzole oral tablets (Rilutek(R)), as well as the safety and tolerability of BHV-0223. Key findings from the clinical program showed that sublingual administration of BHV-0223 (40 mg) achieved similar blood exposures to orally ingested Rilutek (50 mg). In these studies and trials, BHV-0223 was generally well tolerated. Patients also reported the sublingual formulation easy to use in clinical trials in which BHV-0223 was administered to patients with ALS and dysphagia.

BHV-0223 is a sublingually administered, orally dissolving tablet (ODT) that makes use of the unique Zydis(R) ODT fast-dissolve technology. It is being developed under an exclusive worldwide agreement with Catalent. While riluzole is FDA-approved for ALS, existing formulations consist only of an oral tablet taken with water or an oral suspension (thickened liquid). BHV-0223 is designed to be placed under the tongue where it dissolves in seconds and is absorbed by the vasculature, thereby eliminating the need for swallowing.

More than 80% of people living with ALS experience dysphagia at some point in their disease course. Even mild or moderate dysphagia can lead to difficulty managing small oral boluses such as tablets through the swallowing process. The impaired ability to swallow safely puts people with ALS at risk of aspiration and its potentially life-threatening consequences such as aspiration pneumonia.

SOURCE Biohaven Pharmaceutical Holding Company Ltd.