People living with CNS disorders, particularly those relating to mental health, have unique challenges adhering to their prescribed medications. 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 its final pivotal study in 2024.
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.
In January 2024, Lyndra announced that the STARLYNG-1 (LYN-005-C-301) study demonstrated the efficacy of oral weekly risperidone compared to daily Risperdal by meeting the primary endpoint, which included the geometric mean ratio of Week 5 oral weekly risperidone drug levels compared to baseline immediate-release Risperdal drug levels. With these positive results, the study was stopped early according to the pre-defined stopping criteria.
The study also met its secondary endpoints for safety and Positive and Negative Syndrome Scale (PANSS) score, a score used for measuring symptom severity in schizophrenia.
Following the STARLYNG-1 pivotal PK study, Lyndra will conduct the STARLYNG-2 pivotal safety study, a six-month, double-blind study beginning in 2024 in patients with schizophrenia and schizoaffective disorders to characterize the safety profile of Lyndra’s LYNX® drug delivery platform.
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)
