(Boursier.com) — MedinCell announced the start of the Phase 3 study for the second antipsychotic using its long-acting injectable product technology (mdc-TJK program).
The US-led study will assess the efficacy and safety of what may be the first subcutaneous long-acting injectable (LAI) formulation of olanzapine for the treatment of patients with schizophrenia. The integration of the first patients is expected in the coming days.
Teva, MedinCell’s partner, which is funding and driving the regulatory development of the product (TEV-44749), has just released details of the protocol.
mdc-TJK follows on from mdc-IRM (risperidone LAI), the first subcutaneous antipsychotic based on MedinCell’s technology currently under regulatory review by the US FDA, expected to launch in the first half of 2023.
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