Ingrezza Sprinkle(valbenazine)

Ingrezza Sprinkle (valbenazine) is an original 505(b)(1) NDA application (NDA 218390) for a new formulation of valbenazine, which was originally approved for tardive dyskinesia (TD) on April 11, 2017 (NDA 209241) and for Huntington's chorea (HC) on August 18, 2023. The PDUFA Goal Date and Review Completion Date for Ingrezza Sprinkle were both April 30, 2024, with a recommended regulatory action of Approval.

In a pivotal pharmacokinetic study (NBI-98854-1730) involving 38 subjects, the valbenazine OGS capsule sprinkled on applesauce demonstrated a Cmax of 532 ng/mL and an AUCinf of 5811 ng*hr/mL, with a Tmax of 1.25 hours. When swallowed whole, the valbenazine OGS capsule had a Cmax of 684 ng/mL and an AUCinf of 6066 ng*hr/mL, with a Tmax of 1 hour. Compared to the commercial capsule, the OGS capsule sprinkled on applesauce had a Cmax geometric mean ratio of 71.46% and an AUCinf geometric mean ratio of 89.24%. A high-fat meal decreased valbenazine Cmax by 15%.

Safety findings included a boxed warning for potential increases in depression and suicidal ideation and behavior. Warnings for somnolence, QT prolongation, and parkinsonism were also present. Common adverse events in Cohort 1 included headache (33%), nausea (29%), and vomiting (17%). In Cohort 2, arthralgia and headache both had an incidence of 14%.