Method for the treatment of residual symptoms of schizophrenia
AssigneeIntra-Cellular Therapies, Inc.
InventorsKimberly Vanover, Peng Li, Sharon Mates, Robert Davis, Lawrence P. Wennogle
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Abstract
The disclosure provides the use of particular substituted heterocycle fused gamma-carboline compounds as pharmaceuticals for the treatment of residual symptoms of psychosis or schizophrenia. The disclosure also provides novel long acting injectable formulations of particular substituted heterocycle fused gamma-carboline compounds and use of such long acting injectable formulations for the treatment of residual symptoms of psychosis or schizophrenia.
Claims25
A method for the treatment of residual symptoms of schizophrenia as defined in the Positive and Negative Syndrome Scale (PANSS) for Schizophrenia, comprising administering to a patient in need thereof, after treatment of acute symptoms of schizophrenia with an antipsychotic agent, an effective amount of a compound of Formula I:
- wherein:
- X is —O—, —NH— or —N(CH3)—;
- Y is —O—, —C(R2)(OH)—, —C(R3)(OR1) or —C(O)—;
- and
- R1 is —C1-6alkyl or —C(O)—C1-21alkyl, optionally saturated or unsaturated and optionally substituted with one or more hydroxyl or C1-22alkoxy groups wherein such compound hydrolyzes to form the residue of a natural or unnatural, saturated or unsaturated fatty acid;
- R2 is H or —C1-6alkyl;
- and
- R3 is H or —C1-6alkyl;
- in free or pharmaceutically acceptable salt form;
- wherein the patient significantly improves on the Prosocial PANSS Factor change from baseline.
A method for the treatment of residual symptoms of schizophrenia as defined in the Positive and Negative Syndrome Scale (PANSS) for Schizophrenia, comprising administering, after treatment of acute symptoms of schizophrenia with an antopsychotic agent, to a patient in need thereof a long acting injectable composition comprising a PLGA matrix of 75:25 PLA/PLG with either carboxylic acid or carboxylic acid end groups, and an effective amount of a compound of Formula I:
- wherein:
- X is —O—, —NH— or —N(CH3)—;
- Y is —O—, —C(R2)(OH)—, —C(R3)(OR1) or —C(O)—;
- and
- R1 is —C1-6alkyl or —C(O)—C1-21alkyl, optionally saturated or unsaturated and optionally substituted with one or more hydroxy or C1-22alkoxy groups, wherein such compound hydrolyzes to form the residue of a natural or unnatural, saturated or unsaturated fatty acid;
- R2 is H or —C1-6 alkyl;
- and
- R3 is H or —C1-6 alkyl;
- in free or pharmaceutically acceptable salt form;
- wherein the patient significantly improves on the Prosocial PANSS Factor change from baseline.
Dependencies are inferred from the claim text.