The FDA has approved a new drug called Caplyta (lumateperone) to treat schizophrenia in adults. Schizophrenia is a serious mental illness that can cause hallucinations, delusions, and trouble thinking clearly. Caplyta is a type of medicine called an atypical antipsychotic. It is taken once a day, with or without food, and does not require a slow dose increase.
The approval was based on two studies that lasted 4 weeks. In these studies, people taking Caplyta had fewer symptoms of schizophrenia compared to those taking a placebo. The recommended dose is 42 mg once daily. A higher dose (84 mg) did not show extra benefit in one study.
Caplyta is also approved for bipolar depression and as an add-on treatment for major depression. But this approval is specifically for schizophrenia. It offers a new choice for patients, but it is not a cure. Like all medicines, it may cause side effects, and it may not work for everyone.
If you or someone you know has schizophrenia, talk to a doctor. They can help decide if Caplyta is a good option. Do not stop or change any current treatment without medical advice.