Weekly risperidone achieves similar drug levels as daily dose in phase 3 trial
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Key takeaways:
- Weekly risperidone delivered via the Lynx platform achieved drug levels comparable to daily dosing.
- A pivotal safety study of Lynx will begin this year.
An investigational, weekly oral dose of risperidone for schizophrenia achieved drug levels comparable to daily Risperdal in a phase 3 study involving Lynx, a long-acting drug delivery platform developed by Lyndra Therapeutics.
The positive results show that Lynx “may provide a medication option that significantly reduces dosing frequency,” Richard Scranton, MD, MPH, chief medical officer and president of global development at Lyndra, said in a company press release. “For people who rely on risperidone as part of their treatment regimen, oral weekly risperidone could vastly improve medication adherence and outcomes.”
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According to the release, the STARLYNG-1 study evaluated weekly oral risperidone (LYN-005) in 15 mg and 45 mg doses, equivalent to 2 mg and 6 mg daily, in patients with schizophrenia and schizoaffective disorder. The primary endpoint was geometric mean ratio of oral weekly risperidone drug levels vs. baseline immediate-release Risperdal (risperidone, Janssen) levels at week 5.
The study enrolled 46 participants before stopping early, having met the primary endpoint as well as secondary endpoints for safety and symptom severity, the release stated. At 90% confidence limits, weekly risperidone met the endpoints of a one-sided Cmin greater than 0.8, one-sided Cmax less than 1.25 and two-sided Cavg of 0.8 to 1.4. The weekly dose was generally safe and well-tolerated.
A 6-month, double-blind pivotal safety study of Lynx in patients with schizophrenia and schizoaffective disorders is set to begin in the second half of this year.