Teva Pharmaceutical's TEV-749 (olanzapine) has shown significant improvements in schizophrenia symptoms in a Phase III trial, offering a potential new long-acting injectable treatment option. The Phase III SOLARIS trial (NCT05693935) demonstrated improvements in social functioning and quality of life (QoL) over an eight-week treatment period, marking a notable advancement in schizophrenia management. The results, presented at Psych Congress 2024, highlight the potential of TEV-749 to enhance treatment adherence and reduce the risk of serious side effects.
Efficacy of TEV-749 in Improving Social Functioning and Quality of Life
In the SOLARIS trial, TEV-749 was evaluated at three different doses: 318mg, 425mg, and 531mg. The data from the acute treatment phase revealed that all three doses led to improvements in social functioning, as measured by the Personal and Social Performance Scale. Specifically, the 318mg dose achieved a mean improvement of 4.63 points, while the 425mg and 531mg doses showed improvements of 3.15 and 4.93 points, respectively. All three doses demonstrated statistically significant superiority compared to the placebo group. Improvements in QoL, assessed using the Schizophrenia Quality of Life Scale, were also significant across all three doses compared to placebo.
Potential Advantages of Long-Acting Injectable Olanzapine
TEV-749 is administered via subcutaneous injection, which offers potential advantages over traditional oral formulations by improving patient adherence. This aligns with the view that long-lasting injectable treatments can enhance treatment continuity and outcomes in schizophrenia management. The trial data indicated that no patients experienced post-injection delirium/sedation syndrome (PDSS), a significant concern with other long-acting olanzapine formulations. According to Christoph Correll, Professor of Psychiatry at the Zucker School of Medicine in New York, TEV-749 may soon offer schizophrenia treatment for patients taking daily oral olanzapine with a long-acting injectable option that may reduce the risk of this potentially life-threatening side effect.
Safety Profile and Market Potential
The safety profile of TEV-749 was consistent with other approved formulations of olanzapine, with weight gain and injection-site reactions being the main side effects. While Lilly’s Zyprexa, another olanzapine formulation, can lead to weight gain, sedation, and Parkinsonian symptoms, the absence of PDSS in the TEV-749 trial is a notable advantage. Zyprexa generated $1.7 billion last year, according to Lilly’s financials. GlobalData forecasts that, if approved, TEV-749 is set to reach annual sales of $315 million by 2030 in the US.
Evolving Schizophrenia Treatment Landscape
The schizophrenia treatment landscape has seen recent advancements, including the FDA approval of Bristol Myers Squibb's Cobenfy (xanomeline-trospium) in September 2024. Cobenfy introduces a new mechanism of action by targeting cholinergic receptors, potentially avoiding some side effects associated with dopamine receptor-targeting antipsychotics. However, some experts have raised concerns about Cobenfy’s twice-daily dosing schedule, highlighting the importance of medication adherence in schizophrenia treatment.
