Method of treating acute exacerbation of schizophrenia with long-acting injectable depot composition
AssigneeLaboratorios Farmaceuticos Rovi, S.A.
InventorsIbon Gutierro Aduriz, Guillermo Franco Rodriguez
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AssigneeLaboratorios Farmaceuticos Rovi, S.A.
InventorsIbon Gutierro Aduriz, Guillermo Franco Rodriguez
Estimating the term…
A method of treating an episode of acute exacerbation of schizophrenia by intramuscular administration of a long-acting injectable depot composition containing risperidone is provided. The method provides a substantial reduction in PANSS (both positive and negative scales) and CGI-S scores within about eight days after administration of the composition and for up to at least four weeks. The method is used to treat a subject suffering a first-time episode of or a relapse of severe to moderate symptoms associated with schizophrenia. The method does not require loading doses of risperidone in the depot composition and does not require supplementation with oral risperidone after administration of the depot composition.
A method of treating a subject suffering a relapse of moderate to severe psychosis, the method comprising intramuscularly administering to a subject a LAI depot composition comprising a maintenance dose of 25-150 mg of risperidone suspended in a polymeric solution of DMSO and PLGA copolymer, wherein after said administration an implant formed from said composition provides therapeutic plasma concentrations of total active moiety (risperidone and 9-OH-risperidone) within 2-24 hours after administration and continuously for a period of at least about 28 days, thereby providing significant reduction in symptoms associated with said moderate to severe psychosis as determined by total PANSS (including the positive and negative scales) and CGI-S starting from about 8 days after said administering, wherein said method excludes oral supplementation with risperidone and excludes administration of one or more (plural) loading doses of risperidone in LAI depot composition;
A method of improving mental functioning and/or social integration in a human subject experiencing or having recently experienced an episode of acute exacerbation of schizophrenia, the method comprising administering to said subject a long-acting injectable (LAI) depot composition comprising a maintenance dose of 25-150 mg of risperidone suspended in a polymeric solution of DMSO and PLGA copolymer, wherein said composition is administered intramuscularly once about every 28 days or about once monthly, thereby improving mental functioning and/or social integration in said subject as measured using the patient-reported 20-items scale Subjective Well-Being Under Neuroleptics Treatment (SWN-20);
A method of improving mental functioning and/or social integration in a human subject having schizophrenia, wherein said schizophrenia has been previously stabilized by administration of oral risperidone, the method comprising administering to the subject a long-acting injectable (LAI) depot composition comprising a maintenance dose of 25-150 mg of risperidone suspended in a polymeric solution of DMSO and PLGA copolymer, wherein said composition is administered intramuscularly once about every 28 days or about once monthly, thereby improving mental functioning and/or social integration in said subject as measured using the patient-reported 20-items scale Subjective Well-Being Under Neuroleptics Treatment (SWN-20);
Dependencies are inferred from the claim text.