Neurocrine Biosciences, Inc. announced that it will present data from three in vitro dissolution studies exploring the dissolution performance of INGREZZA® (valbenazine) capsule contents through soft foods or a gastrostomy (G-tube) feeding tube. The data (Poster #IND03, Valbenazine Capsule Contents for Potential Administration via Soft Food/Feeding Tube) will be presented at AMDA – The Society for Post-Acute and Long-Term Care Medicine's PALTC23 Annual Conference being held March 9, 2023 to March 12, 2023 in Tampa, Florida. The in vitro data demonstrated that crushing INGREZZA capsule contents did not impact dissolution performance when compared to whole capsules.

Further, mixing the contents with soft foods or liquids of a broad pH range or delivering the contents dissolved in tap water via G-tube resulted in acceptable dissolution performance of INGREZZA. Three studies were conducted to explore the potential of adding crushed INGREZZA capsule contents to soft foods or a gastrostomy feeding tube (G-tube): In Study 1, INGREZZA capsules could be opened manually, with the contents crushed between spoons. Very rapid and complete drug release (>98% in 15 minutes) was observed in all samples, independent of preparation (whole capsules or crushed contents) or dose (40 mg or 80 mg).

For both doses, the average percentage release at first and last collection time points (10 minutes and 60 minutes, respectively) was similar for whole vs crushed in each of two commercial lots of INGREZZA (Lot-A, Lot-B) for the two doses (40 mg and 80 mg) In Study 2, recovery of crushed INGREZZA capsule contents was acceptable within 2 hours of adding them to the tested foods and buffers/fed state simulated gastric fluid (FeSSGF) (assay recovery range: 92% to 102%). Degradants of crushed contents in foods and buffers/FeSSGF were also within acceptable ranges Study 3 showed acceptable INGREZZA recovery following G-tube administration when crushed capsule contents were dissolved in hot or cold water and a cup rinse was performed (assay recovery range: 91% to 97%) Neurocrine Biosciences will also present data on inappropriate use of anticholinergic medication for treating or preventing tardive dyskinesia (TD) in elderly patients [Poster #IND02, Treating Drug-Induced Movement Disorders with Anticholinergics: Implications for Elderly Patients].