Sublingual formulation of riluzole
BHV-0223 is a sublingual, oral disintegrating tablet, or ODT, formulation of riluzole that we are initially developing for the treatment of ALS. ALS is a progressive neurodegenerative motor neuron disease that affects nerve cells in the brain and the spinal cord. ALS affects up to 20,000 individuals in the United States and typically presents in patients with painless muscle weakness, trouble swallowing and muscle atrophy that ultimately progresses to paralysis, impaired breathing and death. Orally administered riluzole, which was approved by the FDA in 1995, remains the only agent shown to extend survival and time to tracheostomy in patients with ALS, although it has significant shortcomings that limit its utility. We believe that BHV-0223 has the potential to significantly improve the treatment of patients with ALS by combining the unique pharmacologic activities of glutamate modulation that are conferred by riluzole with an improved pharmacologic profile that results in easier administration for patients with dysphagia, more predictable pharmacokinetic performance, no food effect, reduced drug load and reduced liver exposure compared to oral riluzole. In December 2016, we received orphan drug designation from the FDA for BHV-0223 in ALS.
Currently, Biohaven has an open treatment protocol Expanded Access Program for BHV-0223 for the indication of Amyotrophic Lateral Sclerosis (ALS). This protocol has been reviewed by the FDA. Healthcare professionals and patients can learn more about the BHV-0223 Expanded Access Program by visiting www.clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT03537807).
Individual patients interested in obtaining access to BHV-0223 therapy must do so via their physician. If you are a physician and would like to discuss the Expanded Access Protocol, contact us at BHV0223.ExpandedAccess@earlyaccesscare.com or call 1-(888) 315-5797 (option 6). All requests will be carefully considered, and a written or oral response will be provided to the treating physician within 2 days of receiving a request.