An antipsychotic proves effective in treating schizophrenia when taken orally weekly rather than daily

An oral formulation of risperidone could be administered weekly instead of daily to treat patients with schizophrenia with the same efficacy, according to a phase III clinical trial published in The Lancet Psychiatry. The study included 83 patients in the United States.

 

11/06/2025 - 00:30 CEST
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Juan Antonio García-Carmona - ensayo esquizofrenia EN

Juan Antonio García-Carmona

Neurologist at Santa Lucía General Hospital in Cartagena, associate professor of Pharmacology at the Catholic University of Murcia (UCAM), researcher in neuropsychiatry at the Murcian Institute for Bio-Health Research (IMIB)

Science Media Centre Spain

The results of the study indicate that LYN-005 provides stable and therapeutic levels of the drug in the body, with efficacy and safety comparable to those of immediate-release risperidone. In addition, patients participating in the trial remained clinically stable and no unexpected adverse effects were observed. This work represents an important milestone: it is the first Phase 3 trial to successfully demonstrate an oral extended-release technology in psychiatric disorders, an advancement that complements and expands the options available, which until now have been dominated by long-acting injectables.

However, the study has some limitations that could diminish its impact on daily clinical practice: the relatively short duration (five weeks), the fact that patients were admitted to a centre or nursing home (they were not outpatients), and the high incidence of gastrointestinal effects, which will need to be monitored in longer-term studies, as well as adherence to treatment in real life.

From a pharmacological point of view, this advance represents a significant contribution to the treatment of schizophrenia and schizoaffective disorder. Until now, patients who refuse injectable treatments have taken their oral antipsychotic medication daily, which in practice often makes adherence to treatment difficult and increases the risk of relapse. With LYN-005, we will have, for the first time, an oral formulation that releases risperidone in a sustained manner over an entire week, allowing therapeutic levels to be maintained. This not only simplifies the medication routine but may also significantly improve clinical stability and quality of life for patients.

This advance represents the first successful validation of this innovative long-acting oral drug delivery technology for psychiatric disorders. If confirmed in clinical practice, this technology could improve the treatment of schizophrenia and other disorders by facilitating oral treatment adherence and thereby improving patients' quality of life.

The author has declared they have no conflicts of interest
EN

Eduard Vieta - ensayo esquizofrenia EN

Eduard Vieta

Researcher of the Centre for Biomedical Research in Mental Health Network (CIBERSAM). Head of the Psychiatry and Psychology Department at the Hospital Clínic de Barcelona and lecturer at the University of Barcelona

Science Media Centre Spain

The work represents an incremental innovation that may have a small impact on the treatment of schizophrenia. Risperidone is a drug that has been used for many years, is effective in this disease and is available in a variety of formulations. As some patients forget to take their medication or are prone to stopping treatment, in addition to the daily tablet, there are injectable forms that are administered every 15 days, every month, every three months and even every six months. In this case, a weekly oral formulation has been shown to be equivalent to daily oral administration, allowing for a lighter medication regimen, which may be useful for patients who forget their daily medication on many days, and an alternative for those who dislike injections. The study design is appropriate for its purpose, and I believe it is another option for treating schizophrenia that offers a very modest improvement.

Conflict of interest: Eduard Vieta declares that he has no conflict of interest with the company that produces this medicine.

EN

Alberto Ortiz Lobo - ensayo esquizofrenia EN

Alberto Ortiz Lobo

Doctor of Medicine and Psychiatrist at the Carlos III Day Hospital - La Paz University Hospital (Madrid)

Science Media Centre Spain

This study was designed and funded by a pharmaceutical company to capitalise on an existing product, risperidone, whose patent had expired. To this end, it proposes a new weekly oral dosage form and conducts a pharmacokinetic analysis lasting only five weeks.

Long-acting preparations may be useful in long-term treatment for people who wish to reduce the frequency of dosing.

On the other hand, daily flexibility in increasing or reducing the dose is lost, and if any side effects occur, they are maintained for longer due to the delay in eliminating the action of the drug. Of the 83 people enrolled in the study, 20 dropped out after the first dose and only half completed it, which may cast doubt on its acceptance and widespread use in healthcare practice.

The author has not responded to our request to declare conflicts of interest
EN
Publications
Long-acting oral weekly risperidone (LYN-005) for schizophrenia in the USA (STARLYNG-1): a multicentre, open-label, non-randomised phase 3 trial
  • Research article
  • Peer reviewed
  • Clinical trial
  • People
Journal
The Lancet Psychiatry
Publication date
Authors

Leslie Citrome et al.

Study types:
  • Research article
  • Peer reviewed
  • Clinical trial
  • People
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