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US 10,646,443 B2Granted
Sustained release olanzapine formulations
AssigneeTeva Pharmaceuticals International GmbH
InventorsCarine Claassen-Punt, Mark Alan Smith, Ling Chen, Ari Andrew Gershon
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Abstract
The disclosure is directed to methods of treating schizophrenia or bipolar disorder by subcutaneously administering a sustained-release dosage form of olanzapine, or a pharmaceutically acceptable salt thereof. Methods of subcutaneously administering olanzapine, or a pharmaceutically acceptable salt thereof, are also described.
Claims58
A method of treating schizophrenia or bipolar disorder in a patient comprising:
- subcutaneously administering to the patient, with a frequency of no more than once per 21 days, a sustained-release pharmaceutical dosage form comprising olanzapine, or a pharmaceutically acceptable salt thereof;
- wherein the dosage form provides a therapeutically effective dose of olanzapine for a period of at least 21 days;
- wherein the upper limit of a 95% Confidence Interval for the Cmax, avg is ≤100 ng/ml;
- and
- wherein said method is performed without monitoring for post-injection delirium/sedation syndrome (PDSS).
2 more elements
A method of administering between about 150 mg and about 900 mg of olanzapine, or a pharmaceutically acceptable salt thereof, to a patient comprising:
- subcutaneously administering to the patient a sustained-release olanzapine pharmaceutical dosage form at a frequency of no more than once per 21 days and provides an upper limit of a 95% Confidence Interval for the Cmax, avg that is ≤100 ng/ml;
- wherein the per-injection risk of PDSS being observed in the patient following the administration is less than 0.07% and/or the per-patient risk of PDSS being observed in the patient following the administration is less than 1.4%.
Dependencies are inferred from the claim text.