Media release

From: The Lancet

The Lancet Psychiatry: Phase clinical 3 trial shows promise for a once weekly oral schizophrenia treatment

A once weekly slow-release formulation of risperidone, a medication used to treat schizophrenia and schizoaffective disorder, maintained therapeutic levels similar to those achieved with daily doses, according to the results of a phase 3 non-randomised controlled trial published in The Lancet Psychiatry journal. The results of the trial are the first successful demonstration of a long-acting oral drug formulation of a second-generation antipsychotic for schizophrenia and schizoaffective disorder. The authors say this formulation could offer a promising alternative to daily oral medications and long-acting injectables, after it has been tested in a full randomised controlled trial, potentially improving adherence and patient autonomy by reducing dosing frequency without compromising therapeutic benefits.

Adherence to a daily treatment regimen can be a challenge for many patients living with schizophrenia and schizoaffective disorder, which can lead to poor health outcomes and increased healthcare costs. The development of longer acting oral treatment options (sustained release over a week) could simplify care and provide better condition management while maintaining consistent therapeutic effects, however, currently no long acting oral antipsychotic formulations exist.

The STARLYNG-1 trial aimed to address this gap by investigating whether a long-acting weekly oral formulation of risperidone (LYN-005) is maintained at consistent levels in the body over time for the treatment of schizophrenia and schizoaffective disorder. Participants were enrolled in the trial from April to December 2023 in the United States (US), and 83 patients first received daily oral risperidone and then received weekly LYN-005 over five weeks at a low (15 mg) or high (45 mg) dose. During the treatment and safety follow-up periods LYN-005 was also generally safe and well tolerated, with gastrointestinal side effects being the most commonly reported issue, and there was only one serious adverse event reported during the trial.

The authors say the results of this study are promising but should be followed up with a randomised controlled trial that investigates whether it proves adherence to medication schedule and shows similar efficacy and risk of relapse to daily oral or long-acting injectable antipsychotics.