Teva Pharmaceuticals, and Medincell have released results from the efficacy portion of the Phase III subcutaneous olanzapine extended-release injection study (SOLARIS) trial evaluating TEV- ‘749 in adult patients with schizophrenia compared to placebo.
Primary and secondary endpoints met
Results demonstrated that TEV-‘749 met its primary endpoint as measured by a change in the PANSS total score from baseline after 8 weeks compared to placebo.
TEV- ‘749 utilises SteadyTeq, a copolymer technology proprietary to Medincell that provides a controlled steady release of olanzapine, the most prescribed 2nd generation antipsychotic for schizophrenia in the US. 1
TEV-‘749 met its primary endpoint across all three dosing groups, with mean difference in change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 8 all being clinically meaningful and statistically significant.
Key secondary endpoints of CGI-S (Clinical Global Impressions – schizophrenia) and PSP (Personal and Social Performance Scale) total score were also statistically significant after adjusting for multiplicity.
No post-injection delirium/sedation observed
No cases of PDSS have been reported to date, after administration of approximately 80% of the target injection number.
Currently, there is no long-acting olanzapine treatment option available for schizophrenia that does not risk post-injection delirium/sedation syndrome (PDSS), so this dosage method could significantly ameliorate patient quality of life.
PDSS is characterised by the sudden and unexpected onset of delirium or sedation within the first several hours of receiving treatment and has been associated with the intramuscular injection of long-acting olanzapine.
TEV-‘749 met its primary endpoint across all three dosing groups
“These encouraging results from the efficacy portion of our Phase III SOLARIS trial demonstrate the potential of TEV- ‘749 to be an effective long-acting treatment option for schizophrenia and further show our dedication to advancing innovative science in mental health and beyond,” said Eric Hughes, Executive Vice President of Global R&D and Chief Medical Officer at Teva.
“Schizophrenia can be a devastating disease for both the people struggling with it as well their families. Schizophrenia is often a chronic life-long disease, but by using medication consistently, people can find the treatment help they deserve. This also has the potential to reduce the burden for not only themselves, but for their caregivers and loved ones as well.”
Additional efficacy and safety findings from the Phase 3 SOLARIS study are planned for presentation at a medical meeting later this year. The long-term safety of TEV-‘749 and incidence of PDSS are also being evaluated in the SOLARIS open-label study (period 2) with safety data topline readout expected in the second half of 2024.