Teva Pharmaceuticals recently shared new safety data from the Phase III SOLARIS trial and a Phase I study regarding extended-release subcutaneous olanzapine, TEV-‘749. This data revealed that none of the patients in the two studies experienced post-injection delirium/sedation syndrome (PDSS). Olanzapine is an atypical antipsychotic that was initially approved by the US Food and Drug Administration (FDA) in 2009. Marketed by Eli Lilly as Zyprexa, it has a longer-acting version known as Zyprexa Relprevv. Although generics of this therapy are available, its use as a long-acting treatment has been restricted due to the risk of developing PDSS, which causes sudden delirium or sedation shortly after receiving treatment.
Zyprexa was a significant product for Lilly, with peak sales surpassing $3 billion in 2001. Teva’s olanzapine extended-release product is expected to reach annual sales of $145 million by 2034 in the US, according to GlobalData. The SOLARIS study (NCT05693935) successfully met its primary endpoint by demonstrating an improvement in symptom severity of schizophrenia, as measured by the Positive and Negative Syndrome Scale (PANSS). The results from these trials were presented at the Annual European College of Neuropsychopharmacology (ECNP) Congress in Milan, Italy.
Dr. Christoph Correll, a professor of psychiatry at the Zucker School of Medicine, highlighted the importance of developing a long-acting olanzapine formulation that poses minimal risk of PDSS. The placebo-controlled SOLARIS trial enrolled 675 patients with schizophrenia and showed positive results with the TEV-‘749 doses. Participants in the study also demonstrated improvements in the clinical global impression severity (CGI-S) scale.
While no cases of PDSS were reported, some treatment-emergent side effects included weight gain, injection site reactions, and erythema. Serious adverse events were seen in a small percentage of patients, with a few participants discontinuing treatment. The safety and tolerability results from the Phase I trial evaluating TEV-‘749 in patients with schizophrenia were also presented at the conference, emphasizing the absence of PDSS in the study.
Teva’s focus on the safety profile of their once-monthly schizophrenia therapy is crucial for patients and healthcare providers. By continuing to gather data and present their findings at conferences, they are contributing to the ongoing research and development in the field of mental health treatment. The results of these trials provide hope for a safer and more effective long-acting treatment option for individuals living with schizophrenia.