Oral Weekly Risperidone for Schizophrenia: Positive Phase 3 Study Data

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New positive pivotal phase 3 study data released on oral weekly risperidone for schizophrenia.

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Lyndra Therapeutics announced positive data from the STARLYNG-1 study, which compared the pharmacokinetic profile of oral weekly risperidone (LYN-005) with immediate-release Risperdal administered daily for adults with schizophrenia and schizoaffective disorder.1

The study assessed oral weekly risperidone 15 mg and 45 mg, which is equivalent to 2 mg and 6 mg daily Risperdal, respectively. Participants included individuals with schizophrenia and schizoaffective disorder who were on a stable oral antipsychotic dose at the start of the study; a total of 90 participants were planned, with an interim analysis after 46 participants. Oral weekly risperidone met the endpoint of a one-sided Cmin of >0.80; a one-sided Cmax of <1.25; and a 2-sided Cavg of 0.80-1.40, with 90% confidence limits. The study also met secondary endpoints for safety and Positive and Negative Syndrome Scale (PANSS) score. Oral weekly risperidone (LYN-005) was generally safe and well tolerated.

“These positive data demonstrate that a single dose of oral weekly risperidone delivers comparable medication levels to daily risperidone, validating that Lyndra’s LYNX® drug delivery platform may provide a medication option that significantly reduces dosing frequency,” said Richard Scranton, MD, MPH, chief medical officer and president of global product development at Lyndra Therapeutics. “For people who rely on risperidone as part of their treatment regimen, oral weekly risperidone could vastly improve medication adherence and outcomes.”

The noted benefit of this drug delivery platform is more consistent medication levels compared with daily dosing via reduction of peak to trough variation.

“The LYNX drug delivery platform has the potential to transform how we take oral medicines, and we are very pleased with the positive interim data for our lead asset oral weekly risperidone. We are eager to bring long-acting oral therapies to patients and are focused on advancing oral weekly risperidone into its remaining pivotal safety trial in 2024,” said Jessica Ballinger, president and CEO of Lyndra Therapeutics.

Reference

1. Lyndra Therapeutics announces positive data from pivotal phase 3 study with oral weekly Risperidone (LYN-005) for schizophrenia. Business Wire. News release. January 4, 2024. https://www.businesswire.com/news/home/20240104163052/en/Lyndra-Therapeutics-Announces-Positive-Data-from-Pivotal-Phase-3-Study-with-Oral-Weekly-Risperidone-LYN-005-for-Schizophrenia

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