Teva Pharmaceuticals’ TEV-479 (olanzapine) has shown statistical improvement in schizophrenia symptoms in a Phase III trial.
The Phase III SOLARIS trial (NCT05693935) demonstrated improvements in social functioning and quality of life (QoL) over an eight-week treatment period.
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In the trial, TEV-479 was assessed at three doses: 318mg, 425mg, and 531mg. Data from the acute treatment phase of the study revealed improvements in social functioning, measured by the Personal and Social Performance Scale. 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 over placebo.
QoL improvements were also significant, as assessed by the Schizophrenia Quality of Life Scale, with all three doses outperforming the placebo. These findings build on the announcement in May 2024 that the trial successfully met its primary and secondary endpoints, along with September 2024 safety data indicating that no patients experienced post-injection delirium/sedation syndrome (PDSS).
Teva presented the new findings at Psych Congress 2024 in Boston, Massachusetts, from 29 October to 2 November.
TEV-479 is administered by subcutaneous injection, presenting potential advantages over traditional oral formulations, and improving patient adherence. This approach aligns with the opinion that long-lasting injectable treatments can improve treatment continuity and outcomes in schizophrenia management.
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By GlobalDataOlanzapine is an atypical antipsychotic and was first approved by the US Food and Drug Administration (FDA) in 2009. It is marketed by Eli Lilly as Zyprexa and a longer-acting version called Zyprexa Relprevv. While generics are available, their use as a long-acting treatment has been limited due to concerns about PDSS, a condition characterised by the sudden onset of delirium or sedation within hours of treatment.
In the announcement accompanying the data, professor of psychiatry at the Zucker School of Medicine in New York Christoph Correll said: “In regard to TEV-‘749 and the potential lack of PDSS, we may soon be able to 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. This is an important advancement for those who may benefit from a long-acting treatment approach.”
This doesn’t mean that TEV-749 will come without side effects. The safety profile of TEV-749 was consistent with other approved formulations of olanzapine, with weight gain and injection-site reactions as the main side effects. Lilly’s Zyprexa can lead to weight gain, sedation, and Parkinsonian symptoms, like other commonly used antipsychotics. Zyprexa generated $1.7bn last year, as per Lilly’s financials. According to GlobalData forecasts, if approved, TEV-479 is set to reach annual sales of $315m by 2030 in the US.
GlobalData is the parent company of Clinical Trials Arena.
This year marked a shift in the schizophrenia treatment landscape with the introduction of a new approach not seen in decades. In September 2024, Bristol Myers Squibb (BMS) secured FDA approval for its first-in-class schizophrenia drug Cobenfy (xanomeline-trospium). The drug introduces a new mechanism of action to the schizophrenia treatment landscape by targeting cholinergic receptors as opposed to dopamine receptors, potentially dodging some of the side effects associated with other antipsychotics.
While the approval has generated excitement, some experts have raised concerns about the drug’s twice-daily dosing schedule. They point out that the effectiveness of a treatment often hinges on consistent medication adherence, which can be particularly challenging for patients with schizophrenia.
