Teva Pharmaceuticals has shared new safety data from the Phase III SOLARIS trial and a Phase I study of extended-release subcutaneous olanzapine, TEV-‘749, showing that none of the patients in the two studies experienced post-injection delirium/sedation syndrome (PDSS).
Olanzapine is an atypical antipsychotic and was first approved by the US Food and Drug Administration (FDA) in 2009. Eli Lilly markets it as Zyprexa and a longer-acting version as Zyprexa Relprevv. Generics of the therapy are also available, however, its use as a long-acting treatment has been limited as it is linked with a risk of developing PDSS. The condition causes the sudden onset of delirium or sedation within hours of receiving treatment. Zyprexa was a breakthrough product for Lilly, generating peak sales of over $3bn in 2001. Clinical Trials Arena‘s parent company GlobalData expects Teva’s olanzapine extended-release product to reach annual sales of $145m by 2034 in the US.
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The SOLARIS study (NCT05693935) met its primary endpoint by showing improvement in symptom severity of schizophrenia, measured using Positive and Negative Syndrome Scale (PANSS). The results from the two trials were presented at the Annual European College of Neuropsychopharmacology (ECNP) Congress taking place from 21 to 24 September in Milan, Italy.
“Developing a long-acting olanzapine formulation that poses potentially no risk of PDSS is crucial in preventing these dangerous episodes that otherwise limit the use of olanzapine to daily oral options,” said Dr Christoph Correll, professor of psychiatry at the Zucker School of Medicine.
The placebo-controlled SOLARIS trial enrolled 675 patients with schizophrenia. The study was divided into two sections, a double-blinded eight-week period one followed by a 48-week open-label extension. At eight weeks, participants who received three different doses of TEV-‘749, corresponding to 20mg/day, 15mg/day and 10mg/day, showed a difference of -9.71 points, -11.25 points, and -9.69 points, respectively, versus placebo compared to baseline.
The participants also met the trial’s secondary endpoint by improving the clinical global impression severity (CGI-S) scale. The patients saw a reduction of 0.47 points, -0.61 points, and -0.53 points versus placebo on high, medium and low doses of TEV-‘749, at eight weeks compared to baseline.
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By GlobalDataWhilst there were no reported cases of PDSS, other treatment-emergent side effects included weight gain along with injection site induration, pain, and erythema. Serious adverse events were seen in 1% of the patients in TEV-‘749 compared to 2% in the placebo group, with 3% of the participants discontinuing treatment in both groups. Topline safety data from the open-label period is expected in the first half of next year.
The safety and tolerability results from the Phase I trial (NCT06319170) evaluating TEV-‘749 in patients with schizophrenia were also presented at the conference. Teva emphasised there was no incidence of PDSS in the study.
