New Study Demonstrates First Successful Long-Acting Oral Drug Delivery for Schizophrenia
Weekly Oral Administration of Risperidone Kept Patients Clinically Stable, Validating a Regimen That Could Transform Daily Medications into Weekly Doses
Managing schizophrenia can become significantly easier and more empowering for patients. A new study authored by Leslie Citrome, M.D., M.P.H., clinical professor of psychiatry and behavioral sciences at New York Medical College, and published in The Lancet Psychiatry, has produced the first successful demonstration of a once-weekly, long-acting oral treatment for the management of schizophrenia and schizoaffective disorder.
“One of the biggest obstacles in the care of people with schizophrenia is that medications are not taken consistently,” said Dr. Citrome. “Identifying effective treatments, like weekly oral administration, can reduce poor health outcomes like relapses, suicides, and re-admission to hospitals in this patient population.”
The phase 3 clinical trial enrolled stable participants with schizophrenia or schizoaffective disorder residing in an inpatient facility to compare the bioavailability of a long-acting oral weekly formulation of risperidone, an antipsychotic commonly used to treat schizophrenia, with daily oral risperidone.
Ultimately, weekly administration of the oral formulation of risperidone provided sustained release of risperidone at therapeutic concentrations with similar bioavailability to immediate-release risperidone. Patients remained clinically stable and expressed no unexpected safety signals. This outcome offers a novel long-acting oral drug delivery technology for schizophrenia and schizoaffective disorders and validates a platform to transform daily medications into weekly formulations.
The availability of diverse, long-acting options would allow for more individualized treatment approaches based on patient preferences, insight, and access. This would make treatment for these conditions more manageable for patients, clinical providers, and caretakers alike, and could ultimately lead to better overall outcomes.
The study was sponsored by Lyndra Therapeutics, with additional contributions from researchers and academic investigators at Massachusetts Institute of Technology, Harvard Medical School, and Broad Institute of MIT and Harvard.
