MONTPELLIER, France - Teva Pharmaceutical Industries (NYSE:TEVA) Ltd. has announced the completion of patient enrollment for its Phase 3 trial of mdc-TJK, a potential new treatment for schizophrenia. The trial has registered 640 participants across the European Union and the United States, with results anticipated in the latter half of 2024.
The drug, mdc-TJK (TEV-44749), is a once-monthly subcutaneous injection and represents an atypical antipsychotic olanzapine formulation. It is being developed as a long-acting option that could potentially be the first of its kind to offer a favorable safety profile. This development comes as a significant step, especially considering the current long-acting injectable (LAI) olanzapine carries an FDA black box warning for Post injection Delirium/Sedation Syndrome (PDSS), which has limited its use.
Teva is leading the development and will handle the global commercialization of this olanzapine LAI. MedinCell, a biopharmaceutical company specializing in long-acting injectable drugs, stands to receive up to $117 million in development and commercial milestones for mdc-TJK, along with royalties on net sales.
MedinCell's proprietary BEPO® technology, which controls drug delivery over extended periods, has already seen success with the FDA approval of UZEDY™, a treatment for schizophrenia, in April 2023. UZEDY™ is now available in the United States through Teva, under the licensed name SteadyTeq™.
The collaboration between Teva and MedinCell underscores a commitment to advancing treatment options for schizophrenia, a chronic brain disorder that affects about 1% of the population worldwide. The completion of enrollment for the mdc-TJK trial marks a milestone in their joint efforts to enhance therapeutic effectiveness and patient compliance.
This report is based on a press release statement.
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