Lumateperone Receives FDA Approval For Schizophrenia in Adults

A novel antipsychotic has received approval from the US Food and Drug Administration (FDA) for the treatment of schizophrenia in adults.

Intra-Cellular Therapies announced early Monday morning lumateperone (CAPLYTA) had received approval from the FDA and the company expects the treatment to be available in late Q1 2020.

“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,” 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.

The approval of oral, once-daily 42 mg lumateperone, which received a Fast Track designation from the FDA in November 2017, is backed by more than 20 clinical trials with data from more than 1900 subjects. With approximately 2.4 million adults with schizophrenia in the United States, the potent serotonin 5-HT2A receptor antagonist, a DPPM acting as a presynaptic partial agonist and postsynaptic antagonist at dopamine D2 receptors, a dopamine D1 receptor-dependent indirect modulator of glutamate, and a serotonin reuptake inhibitor represents a new option to meet the ongoing unmet need for treatments.

In 2 placebo-controlled trials, lumateperone demonstrated a statistically significant separation from placebo in Positive and Negative Syndrome Scale (PANSS) total score, according to a release from Intra-Cellular therapies. The release also pointed out pooled data from short term studies indicated mean changes from baseline in weight gain, fasting glucose, triglycerides, and total cholesterol were similar between patients who received lumateperone and placebo.

In the 2 trials, the most common adverse reactions for 42 mg lumateperone compared with placebo were somnolence/sedation and dry mouth. Additionally, Intra-Cellular Therapies' release noted the incidence of extrapyramidal symptoms in the pooled studies was 6.7% for lumateperone and 6.3% for placebo.

The full Prescribing Information for lumateperone outlines patients should avoid concomitant use with CYP3A4 inducers and moderate or strong CYP3A4 inhibitors. It also states lumateperone is not approved for the treatment of patients with dementia-related psychosis.

“This approval represents the culmination of years of scientific research. We are especially grateful to the patients, their caregivers, and the healthcare professionals who have contributed to the development of Caplyta,” said Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies.

While it has not received FDA approvals for any such conditions, Intra-Cellular Therapies is currently developing lumateperone for the treatment of bipolar depression, behavioral disturbances in with dementia, including Alzheimer's disease, depression, and other neuropsychiatric and neurological disorders.