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An extended release, ultra-long acting antipsychotic takes another step forward in the approval process.
Lyndra Therapeutics announced the positive outcome of an end-of-phase 2 meeting with the US Food and Drug Administration (FDA) suggesting a clear path to approval for its weekly risperidone for the treatment of schizophrenia, LYN-005. This treatment is designed as the first-ever oral, ultra-long-acting, extended-release therapy.1
The company plans to initiate its pivotal program for LYN-005 in early 2022.
“We are grateful to the FDA for their guidance as we design this pivotal program. Transforming the patient experience via oral therapies that achieve consistent plasma drug concentrations at target therapeutic levels for an entire week is one of our key goals,” said Patricia Hurter, PhD, Chief Executive Officer of Lyndra Therapeutics. “This pivotal program allows us to deliver swiftly on the unmet need for ultra-long-acting oral therapies that have the potential to have an enormous and positive impact for patients and caregivers. We hope that the availability of an oral, once-weekly risperidone product will provide a valuable option for those who struggle with adherence but prefer an oral formulation.”
Lyndra and the FDA agreed on the necessity of 2 key elements of this program: 1) a 90-person pharmacokinetic comparability study that builds on the previously established safety and efficacy profile of risperidone, and 2) a 6-month double-blind safety study to characterize the safety profile of the dosage form. Both studies will evaluate LYN-005 at weekly doses ranging from 2 to 6 mg daily, and will support indications in schizophrenia, bipolar mania, and bipolar 1 disorder.
“The FDA provided valuable feedback during the end-of-phase 2 meeting on trial design, manufacturing and control strategy and Lyndra’s path forward as we pursue the pivotal program,” said Chief Medical Officer of Lyndra Therapeutics, Richard Scranton, MD, MPH. “The productive and collaborative nature of these meetings has allowed us to develop a clear and direct course of action as we pursue the tremendous potential of LYN-005.”
To read more on previous studies of LYN-005, see Extended-Release Risperidone Capsule Making Waves.2
1. Lyndra Therapeutics announces positive outcome of end-of-phase 2 meeting with the FDA for Lyndra’s weekly risperidone (LYN-005) for the treatment of adults with schizophrenia and other indications. News release. July 19, 2021. https://www.businesswire.com/news/home/20210719005181/en/Lyndra-Therapeutics-Announces-Positive-Outcome-of-End-of-Phase-2-Meeting-with-the-FDA-for-Lyndra’s-Weekly-Risperidone-LYN-005-for-the-Treatment-of-Adults-with-Schizophrenia-and-Other-Indications
2. Kuntz L. Extended-release risperidone capsule making waves. Psychiatric Times. April 19, 2021. https://www.psychiatrictimes.com/view/extended-release-risperidone-capsule-making-waves