(RxWiki News) The US Food and Drug Administration (FDA) has approved a new treatment for bipolar disorder.
This medication, called Caplyta (lumateperone), was already approved to treat schizophrenia in 2019. Now, the FDA has approved it to treat depressive episodes tied to bipolar I and II disorders.
The FDA approved Caplyta to be used either alone or in combination with lithium or valproate in adults with bipolar disorder.
Caplyta received this new indication based on the results of two studies. Both studies found that the drug improved depressive symptoms tied to bipolar I and bipolar II disorder. This appeared to be true when Caplyta was used alone or in combination with valproate or lithium.
This medication is to be taken once a day with or without food. It is not approved for use in children or anyone who has psychosis related to dementia.
Common side effects of Caplyta included dry mouth, nausea, dizziness and drowsiness.
Possible serious side effects of Caplyta included stroke, uncontrolled body movements, suicidal thoughts and actions, low blood pressure, seizures, low white blood cell count, neuroleptic malignant syndrome and others.
Talk to your health care provider about the best medication for your health condition.
Intra-Cellular Therapies, Inc., manufactures Caplyta.