In This Article:
MONTPELLIER, France, March 31, 2025--(BUSINESS WIRE)--Regulatory News:
Medincell (Paris:MEDCL):
More than 92% of schizophrenia patients taking Olanzapine LAI in the Phase 3 SOLARIS survey were satisfied or very satisfied with the initiation regimen, dosing schedule and trial medication1.
Richard Malamut, Chief Medical Officer at Medincell, commented: "Patient and healthcare professional satisfaction with treatment options is critical to successfully managing schizophrenia. In addition to positive efficacy results2, the Phase 3 trial of our long-acting injectable formulation of olanzapine has demonstrated promising potential in addressing the significant challenge of PDSS3,4. Encouraging early clinical feedback further indicates that the key features enabled by our technology - such as a convenient dosing schedule, straightforward initiation regimen, and subcutaneous administration - have been very well received. These advantages could be instrumental in expanding treatment access for more individuals living with schizophrenia."
These survey results were presented by Teva as part of a large set of schizophrenia data at the SIRS 2025, taking place from March 29 to April 2 in Chicago (Teva’s press release).
List schizophrenia data presented by Teva at SIRS 2025
Olanzapine LAI (mdc-TJK / TEV-‘749)
-
(De novo) Patient and healthcare professional attitudes and trial experiences with a subcutaneous long-acting injectable olanzapine (TV-44749) for the treatment of schizophrenia
UZEDY (risperidone):
-
(De novo) Predictors of response and non-response to treatment for schizophrenia: machine learning analysis of patients treated with TV-46000 or placebo in the RISE study
Schizophrenia Treatment Landscape:
-
(De novo) Healthcare professionals’ attitudes toward use of long-acting injectable antipsychotics for schizophrenia treatment differ among settings of care: ADVANCE survey results
-
(De novo) The evolving schizophrenia treatment landscape in the United States: A real-world claims analysis of treatment patterns and use of long-acting injectable antipsychotics
-
(De novo) Real-world antipsychotic prescription patterns among patients with schizophrenia in Australia: Results from the ARIEL study
-
(De novo) Country-specific factors influencing patients’ willingness to use a long-acting injectable antipsychotic to treat schizophrenia: patient and caregiver ADVANCE survey results
-
(De novo) Patient and caregiver engagement to support the development of clinical trials in adolescents living with schizophrenia
Olanzapine LAI (mdc-TJK / TEV-‘749) is an investigational, once-monthly, subcutaneous long-acting injection of the atypical antipsychotic olanzapine for the treatment of schizophrenia. This is the second drug within the partnership with Teva that uses Medincell’s co-polymer technology (licensed to Teva under the name SteadyTeq™) to generate a controlled steady release of drug throughout the dosing interval. Teva is currently preparing for regulatory submission and launch of Olanzapine LAI, with long-term full safety data expected to be released in Q2 2025 and an NDA submission anticipated in H2 2025. UZEDY®, the other drug, was approved by the US FDA in April 2023.