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)
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.