Neurocrine Biosciences, Inc.NBIX

Neurocrine Biosciences, Inc. (NBIX) focuses on neurology and psychiatry. Their drug, INGREZZA (valbenazine), is indicated for the treatment of adults with tardive dyskinesia. The original capsule formulation of valbenazine received approval for tardive dyskinesia on April 11, 2017, and for Huntington's chorea on August 18, 2023. A new formulation, Ingrezza Sprinkle, is currently under review with a PDUFA Goal Date of April 30, 2024.

Clinical studies for INGREZZA involved 445 patients over 6 weeks in three placebo-controlled studies. The mean age of patients was 56 years, with an age range of 26 to 84 years. In these studies, 85% of patients were taking atypical antipsychotics at study entry, and 27% were taking typical antipsychotics. Discontinuation due to adverse reactions was 3% for INGREZZA compared to 2% for placebo.

Safety findings for INGREZZA include a somnolence incidence of 10.9% (vs 4.2% for placebo), headache incidence of 3.4% (vs 2.7% for placebo), and parkinson-like adverse events at 3% (vs <1% for placebo). Other reported adverse events include anticholinergic effects at 5.4% (vs 4.9% for placebo), balance disorders/fall at 4.1% (vs 2.2% for placebo), akathisia at 2.7% (vs 0.5% for placebo), vomiting at 2.6% (vs 0.6% for placebo), nausea at 2.3% (vs 2.1% for placebo), and arthralgia at 2.3% (vs 0.5% for placebo). QT prolongation was observed with a mean of 11.7 msec and an upper bound of 14.7 msec.