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Teva Pharmaceuticals (Teva) and MedinCell recently announced that the US Food and Drug Administration (FDA) has accepted TV-46000/mdc-IRM (risperidone sustained-release injection suspension, for subcutaneous injection) for the treatment of schizophrenia New Drug Application (NDA)
.
Risperidone is a commonly used clinical drug for schizophrenia
The NDA is based on data from 2 key Phase 3 studies: TV46000-CNS-30072 (RISE study-risperidone subcutaneous sustained release study) and TV46000-CNS-30078 (SHINE study-testing the effectiveness of TV-46000 in the maintenance treatment of schizophrenia Security research)
.
These studies evaluated the effectiveness, long-term safety, and tolerability of TV-46000 (once a month or once every 2 months, subcutaneously) for the treatment of patients with schizophrenia
Teva will continue to lead the clinical development and regulatory process, and is responsible for the commercialization of the drug.
MedinCell is eligible for development milestone payments, royalties based on net sales, and future business milestone payments
.
MedinCell is a clinical-stage pharmaceutical company that combines its patented BEPO® technology with known and marketed active ingredients to develop long-acting injection products in various therapeutic fields, control and extend the release of active pharmaceutical ingredients, and improve treatment compliance Sex
Risperidone-risperidone chemical structure (picture source: ebmconsult.
com)
Schizophrenia (schizophrenia) is a chronic, progressive, and severely debilitating mental illness that affects people's thinking, feeling, and behavior
.
Patients experience a range of symptoms, including delusions, hallucinations, speech or behavior disturbances, and cognitive impairment
The long-term course of schizophrenia is characterized by partial or complete remission of seizure events disrupted by relapse.
Relapse usually occurs in psychiatric emergencies and requires hospitalization
.
Approximately 80% of patients experience multiple relapses during the first 5 years of treatment, and each relapse has the biological risks of loss of function, treatment refractory and changes in brain morphology
Note: The original text has been deleted
Original source: Teva and MedinCell Announce FDA Acceptance of New Drug Application for TV-46000/mdc-IRM as a Treatment for Patients with Schizophrenia
