Medical Professionals Reference (MPR)Study Shows Weekly Oral Risperidone Comparable to Daily Doses for Schizophrenia

LYN-005 Demonstrates Comparable Efficacy to Daily Risperidone

In a significant advancement for the management of schizophrenia and schizoaffective disorder, recent phase 3 study findings herald LYN-005, an investigational long-acting oral capsule formulation of risperidone, as a promising weekly treatment option. The STARLYNG-1 study showcased its pharmacokinetic (PK) profile, revealing comparable medication levels and maintained symptom scores versus the standard daily administration, potentially offering enhanced compliance and improved quality of life for patients.

Key Points:

• LYN-005 is a novel, investigational long-acting oral capsule formulation of the atypical antipsychotic risperidone designed for weekly administration.
• Positive phase 3 study results indicate that LYN-005 has a comparable pharmacokinetic (PK) profile to immediate-release oral daily risperidone in adults with schizophrenia and schizoaffective disorder.
• The STARLYNG-1 study, an open-label, parallel-group trial, involved 90 adults, with interim analysis data from 46 participants highlighting the efficacy of LYN-005 in maintaining therapeutic medication levels and symptom scores.
• Participants received a run-in dose of immediate-release risperidone once daily for 7 days, followed by oral weekly doses of LYN-005, either 15mg (equivalent to 2mg of daily risperidone) or 45mg (equivalent to 6mg of daily risperidone).
• The primary endpoint of comparable medication levels to daily risperidone was met at week 5, with LYN-005 also maintaining Positive and Negative Syndrome Scale (PANSS) scores as a secondary endpoint.
• Lyndra Therapeutics, the developer of LYN-005, plans to conduct a 6-month, double-blind study to further assess safety, set to begin in the second half of 2024.

HCN Medical Memo
The open-label, parallel-group STARLYNG-1 study enrolled a total of 90 adults with schizophrenia or schizoaffective disorder who were on a stable dose of an oral antipsychotic medication.

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