Intra-Cellular Therapies said its drug to prevent relapses in schizophrenia patients met the main goal of a late-stage trial.
Schizophrenia relapse is the return of symptoms after partial recovery from the illness. It's a common characteristic of schizophrenia, with up to 81.9% of people with the condition experiencing a relapse within five years of diagnosis.
The oral drug, lumateperone, showed a 63% reduction in risk of relapse compared to a placebo.
Lumateperone is also under development as an adjunctive therapy for Major Depressive Disorder (MDD). The company plans to submit a marketing application for the drug in MDD in the fourth quarter of the year.
Currently approved schizophrenia drugs include Vanda Pharmaceuticals' Fanapt, AbbVie's Vraylar and Bristol Myers Squibb's Cobenfy.
Schizophrenia, which causes persistent delusions and hallucinations, affects about 24 million people worldwide, according to the World Health Organization.