Expanded Access Protocol for BHV-0223/Zydis SL (Sublingual Disintegrating Riluzole Tablets)
Oral riluzole is FDA-approved for the treatment of amyotrophic lateral sclerosis (ALS). These standard tablets may be difficult for people with ALS to take as directed, because of trouble swallowing pills, the requirement for fasting (not eating) around each dose, or some other reason.
By contrast, when BHV-0223 is placed under the tongue, it rapidly dissolves and does not require swallowing. In addition, because it is absorbed under the tongue the effect of food in the stomach may be less of an issue. Finally, clinical research studies demonstrated that the lower dose of riluzole in BHV-0223 administered under the tongue achieved similar blood levels to a standard oral riluzole tablet. This means that BHV-0223 may pose a lower risk of riluzole associated side-effects, such as liver test abnormalities.
BHV-0223 will be made available in this program at no cost to participants, until the time that it becomes available by prescription.
Principal Investigator: Jeremy Shefner, MD, PhD
Jacquelyn Nicolari, RN