Christoph U Correll1, Kimberly E Vanover2, Robert E Davis3, Richard Chen4, Andrew Satlin2, Sharon Mates4. 1. The Zucker Hillside Hospital, Department of Psychiatry, Northwell Health, Glen Oaks, NY, USA; Zucker School of Medicine at Hofstra/Northwell, Department of Psychiatry and Molecular Medicine, Hempstead, NY, USA; Charité Universitätsmedizin Berlin, Department of Child and Adolescent Psychiatry, Berlin, Germany. 2. Former employee of Intra-Cellular Therapies, Inc., 430 East 29th Street, Suite 900, New York, NY, USA. 3. Intra-Cellular Therapies, Inc., Alexandria Center for Life Science, 430 East 29(th) Street, Suite 900, New York, NY, USA. Electronic address: rdavis@itci-inc.com. 4. Intra-Cellular Therapies, Inc., Alexandria Center for Life Science, 430 East 29(th) Street, Suite 900, New York, NY, USA.
Abstract
BACKGROUND: Lumateperone is a mechanistically novel agent FDA-approved for the treatment of schizophrenia. Efficacy and favorable tolerability of lumateperone were demonstrated in 2 short-term placebo-controlled studies in patients with schizophrenia. This open-label study investigated the short-term safety/tolerability of lumateperone in outpatients with stable schizophrenia switched from previous antipsychotic treatment. METHODS: Adult outpatients with stable schizophrenia were switched from previous antipsychotics to lumateperone 42 mg once daily for six weeks, then patients were switched back to previous or another approved antipsychotic for 2 weeks. The primary objective assessed adverse events (AE), vital signs, laboratory tests, and extrapyramidal symptoms (EPS). Schizophrenia symptoms were assessed using the Positive and Negative Syndrome Scale (PANSS). RESULTS: Among 301 patients switched to lumateperone (study completion=71.2%), treatment-emergent AEs (TEAEs) occurred in 137 patients (45.5%), with 92 (30.6%) experiencing a drug-related TEAE. The most common drug-related TEAEs were somnolence (6.6%), headache (5.3%), and dry mouth (5.3%). Most TEAEs were mild or moderate in severity. EPS-related TEAEs were rare (1.0%). There were significant decreases from previous antipsychotics baseline in total cholesterol (P<.01), low-density lipoprotein cholesterol (P<.05), body weight (P<.01), and prolactin (P<.01); most of these parameters worsened within 2 weeks of resuming other antipsychotic treatment. PANSS Total scores remained stable relative to previous antipsychotics baseline during lumateperone treatment. CONCLUSIONS: In outpatients with stable schizophrenia, lumateperone was well tolerated with low risk of cardiometabolic and EPS adverse effects and stably maintained or improved schizophrenia symptoms. These data further support the safety, tolerability, and effectiveness of lumateperone in patients with schizophrenia.
BACKGROUND:Lumateperone is a mechanistically novel agent FDA-approved for the treatment of schizophrenia. Efficacy and favorable tolerability of lumateperone were demonstrated in 2 short-term placebo-controlled studies in patients with schizophrenia. This open-label study investigated the short-term safety/tolerability of lumateperone in outpatients with stable schizophrenia switched from previous antipsychotic treatment. METHODS: Adult outpatients with stable schizophrenia were switched from previous antipsychotics to lumateperone 42 mg once daily for six weeks, then patients were switched back to previous or another approved antipsychotic for 2 weeks. The primary objective assessed adverse events (AE), vital signs, laboratory tests, and extrapyramidal symptoms (EPS). Schizophrenia symptoms were assessed using the Positive and Negative Syndrome Scale (PANSS). RESULTS: Among 301 patients switched to lumateperone (study completion=71.2%), treatment-emergent AEs (TEAEs) occurred in 137 patients (45.5%), with 92 (30.6%) experiencing a drug-related TEAE. The most common drug-related TEAEs were somnolence (6.6%), headache (5.3%), and dry mouth (5.3%). Most TEAEs were mild or moderate in severity. EPS-related TEAEs were rare (1.0%). There were significant decreases from previous antipsychotics baseline in total cholesterol (P<.01), low-density lipoprotein cholesterol (P<.05), body weight (P<.01), and prolactin (P<.01); most of these parameters worsened within 2 weeks of resuming other antipsychotic treatment. PANSS Total scores remained stable relative to previous antipsychotics baseline during lumateperone treatment. CONCLUSIONS: In outpatients with stable schizophrenia, lumateperone was well tolerated with low risk of cardiometabolic and EPS adverse effects and stably maintained or improved schizophrenia symptoms. These data further support the safety, tolerability, and effectiveness of lumateperone in patients with schizophrenia.