Encouraging data revealed for schizophrenia long-acting injectables
Posted: 5 November 2024 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
Key Phase III and real-world data highlight potential advancements in long-acting injectable treatment options for schizophrenia, Teva and Medincell share.
New data presented at Psych Congress 2024 has shown that the olanzapine long-acting injectable (LAI) TEV-‘749 / mdc-TJK demonstrated “significant improvement” in social functioning and quality of life in adults with schizophrenia. This was based on findings from the initial period (up to week 8) of the Phase III SOLARIS trial.
According to Medincell, TEV-‘749 could be the first long-acting olanzapine medication with a favourable safety profile, because “other LAIs of olanzapine have been associated with a [US] FDA black box warning for PDSS that limits their use”.
Results also showed that to date, there have been no incidents of post-injection delirium/sedation syndrome (PDSS), according to Teva. “This is crucial because the risk of PDSS, along with the associated postinjection monitoring requirement, has been a major barrier to the use of the approved intramuscular olanzapine LAI product,” explained Richard Malamut, Chief Medical Officer of Medincell.
Overall impact of the findings of the long-acting injectables
[Having] no incidents of post-injection delirium/sedation syndrome (PDSS)… is crucial because the risk of PDSS, along with the associated postinjection monitoring requirement, has been a major barrier to the use of the approved intramuscular olanzapine LAI product”
Therefore “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,” stated Dr Christoph Correll, Professor of Psychiatry at the Zucker School of Medicine, US.
“These new data are quite impactful as improvements in social functioning and quality of life would represent a substantial benefit for people living with schizophrenia and their families. This is an important addition to the positive efficacy results for the primary endpoint of the Phase III study that were announced last May,” Malamut added.
Furthermore, Teva shared that real-world analyses found that subcutaneous UZEDY® (risperidone) long acting injectable provided high use and adherence rates in adults with the mental health condition who experience barriers to treatment. A lines of therapy analysis found that UZEDY was employed a first-line option at 12 percent, Teva noted.
Teva is leading clinical development, the regulatory process and commercialisation of UZEDY and TEV-‘749.
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