People living with CNS disorders, particularly those relating to mental health, have unique challenges adhering to their prescribed medications. Lyndra’s long-acting oral therapies have the potential to increase adherence, thus preventing relapses and improving outcomes, while freeing people from the burden of daily pills and simplifying their lives.
Despite effective treatments, medication adherence in schizophrenia and bipolar disorder is a significant issue with quantifiable negative impacts on health and costs. Lyndra is creating the first long-acting oral treatment for people living with schizophrenia and bipolar 1 disorder: oral weekly risperidone (LYN-005). Risperidone is one of the most prescribed treatments for patients with schizophrenia.14 Lyndra’s oral weekly risperidone (LYN-005) is planned to begin pivotal clinical trials in the first half of 2023.
Lyndra has taken a thoughtful approach to demonstrating the value of its long-acting oral technology, which is why the company has prioritized oral weekly risperidone for the treatment of people living with schizophrenia or bipolar 1 disorder.
Staying adherent to prescribed medicines can be challenging for individuals living with CNS conditions and their caregivers and nonadherence can increase the risk of relapse and hospitalization, also severely impacting quality of life.
While many effective treatments exist, people living with these conditions often struggle with poor adherence, which in turn leads to many negative health outcomes. A stable and fulfilling life for people living with schizophrenia and bipolar 1 disorder is possible with consistent medication and support. By dramatically reducing dosing frequency, Lyndra’s long-acting oral therapies have the potential to increase adherence, prevent relapses and improve outcomes, while also freeing people from the burden of daily pills and simplifying their lives.
The results of the Phase 2 study of oral weekly risperidone (LYN-005) provided proof of concept for the LYNX™ drug delivery platform. The Phase 2 data presented in April 2021 showed a sustained release of risperidone from LYN-005 over seven days in the target dosing range of oral daily (immediate release) risperidone. LYN-005 was safe and well-tolerated. Most adverse events were mild and transient, decreasing with repeat dosing.
Based on the outcome of a successful End of Phase 2 meeting with the FDA in June 2021, Lyndra is planning to initiate pivotal clinical trials for oral weekly risperidone (LYN-005) in the first half of 2023. One pivotal study will be a pharmacokinetic (PK) comparability study, comparing LYN-005 to daily (immediate release) risperidone. This study aims to build upon the previously established safety/efficacy of daily risperidone.
As part of its pivotal program for oral weekly risperidone (LYN-005), Lyndra is planning to initiate a pivotal safety study in 2024. This double-blind study will test the safety of oral weekly risperidone compared to daily (immediate release) pills.
14. IQVIA Analytics Link Net Sales, November 2021
15. Patient Unmet Needs Survey (Q3’21; n=1645 patients and caregivers)
16. Schizophrenia and Psychosis Action Alliance, “Societal Costs of Schizophrenia and Related Disorders Infographic,” https://sczaction.org/wp-content/uploads/2021/07/Final-Infographic.pdf
17. Risperidone Prescriber Survey (Q3’21; n=77 Psychs)
18. Patient Unmet Needs Survey (Q3’21; n=1645 patients and caregivers)
