The US Food and Drug Administration (FDA) has approved an atypical antipsychotic Caplyta (lumateperone; Intra-Cellular Therapies) for the treating schizophrenia in adult patients.
Confirmation to market the drug comes from two double-blinded studies that evaluated Caplyta in schizophrenic patients for 28 days. Results were affirming and showed the taking 42mg of Caplyta daily was enough to reduce schizophrenic symptoms from baseline to Day 28.
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Like every other drug, safety is a priority Caplyta is no exception. The drug comes with a boxed warning for increased mortality rates among elderly patients receiving the medication for dementia-related psychosis. The most persist side-effects was sedation and dry mouth.
“Schizophrenia is a complex disease that severely impacts patients and their families,” said Jeffrey A. Lieberman, MD, Lawrence C. Kolb Professor and Chairman of Psychiatry, Columbia University, College of Physicians and Surgeons and Director, New York State Psychiatric Institute. “Effective treatment provided in a timely fashion can be game-changing for people living with schizophrenia. The efficacy and safety profile of Caplyta approved by the FDA, offers healthcare providers an important new option for treating people living with schizophrenia.”
How does Caplyta work? The exact mechanism remains a mystery but it is generally believed to work its magic by antagonizing the activity of particular serotonin receptors known the 5-HT2A and the postsynaptic activity of the central dopamine D2 receptors.
Caplyat will be marketed in 42mg capsules provided in 30-count boxes.
Source: IntraCellularTherapies
