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project info
Start date: 2 January 2020
End date: 31 December 2023
funding
Fund: European Regional Development Fund (ERDF)
Total budget: 3 067 134,89 €
EU contribution: 1 876 417,85 € (61,18%)
programme
Programming period: 2014-2021
Managing authority: Zarząd Województwa Łódzkiego, obsługiwany przez: Departament Polityki Regionalnej, Departament ds. Regionalnego Programu Operacyjnego, Departament Finansów, Departament Europejskiego Funduszu Społecznego, Departament Promocji

Development and implementation of an innovative medicinal product in the form of an ODT tablet containing the second generation antipsychotic substance.

The aim of the project is to develop and then implement on the Polish market and selected European markets a drug containing lurasidone in an innovative form of ODT tablet (dispersible in the mouth) in 5 strengths (so far only 3 strengths are available on the European market), bioequivalent to the reference product Latuda. This product will be mainly dedicated to people suffering from schizophrenia, with the Applicant planning to obtain an extension of the indication to treat schizophrenia not only in adults but also in adolescents (> 13 years of age), treatment of depressive episodes in bipolar disorder type I in adults and children > 10 years of age, and in combination with lithium or valproate, treatment of depressive episodes in the course of bipolar disorder type I in adults. These indications include film-coated tablets with lurasidone on the US market. According to WHO data, more than 21 million people suffer from schizophrenia worldwide. According to the report "Schizophrenia. The role of carers in creating cooperation', the number of patients exceeds 50 million. The maturity rate of schizophrenia is estimated at 15-30 per 100 000 persons per year. In Poland, the prevalence of schizophrenia is around 400,000 patients. The most common diseases are men aged 15-25 and women aged 25-35. The goal of the project will be achieved as a result of the implementation of 5 stages of R & D. In Stage 1, preformulation, analytical, formulation and taste tests on the rat model will be carried out. The stage will end with formulations for the clinical pilot study (Stage 2). Stage 3 envisages the possible reformulation of prototypes and the development of a registration series, including for the basic study. In the next step, a basic bioequivalence study will be performed on healthy subjects with the use of a test medicinal product. In the last 5 Stage, the stability of the finished product under different storage conditions will be tested.

Flag of Poland  Łódzki, Poland