Lurasidone novel dosage regimens and use thereof for the treatment, prevention, and/or management of at least one cns disorder
AssigneeDainippon Sumitomo Pharma Co., Ltd.
InventorAntony D Loebel
Life of this patent
Estimating the term…
Abstract
Dosage regimens for at least one compound chosen from Iurasidone and pharmaceutically acceptable salts, solvates, clathrates, and stereoisomers thereof are disclosed as are kits and methods for treatment and/or prevention of at least one CNS disorder such as, for example, mixed depression and bipolar disorder, and management of at least one CNS disorder, such as improving quality of life and reversing impairment in learning and memory associated with schizophrenia, comprising administering to a patient a therapeutically or prophylactically effective amount of at least one compound chosen from lurasidone and pharmaceutically acceptable salts, solvates, clathrates, and stereoisomers thereof.
Claims42
A method of treating at least one CNS disorder chosen from bipolar disorder and mixed depression comprising administering to a patient in need thereof at least one compound chosen from lurasidone and a pharmaceutically acceptable salt thereof.
A method of improving cognitive impairment in a patient having at least one CNS disorder comprising administering to a patient in need thereof at least one compound chosen from lurasidone and a pharmaceutically acceptable salt thereof.
A method of reducing side effects associated with at least one CNS disorder and/or treatment of at least one CNS disorder comprising administering to a patient in need thereof at least one compound chosen from lurasidone and a pharmaceutically acceptable salt thereof.
A method of treating a patient having at least one CNS disorder comprising:
- administering to the patient an initial dose of at least one compound chosen from lurasidone and a pharmaceutically acceptable salt thereof for a first dosage period;
- classifying the patient as an early responder or a non-responder based on a response indicator;
- determining a second dose and dosage period of at least one compound chosen from lurasidone and a pharmaceutically acceptable salt thereof based on the response indicator;
- administering the second dose of the at least one compound to the patient over the second dosage period;
- wherein the second dose and second dosage period improve the safety and/or efficacy of treatment with at least one compound chosen from lurasidone and a pharmaceutically acceptable salt thereof.
A method of treating at least one CNS disorder comprising administering to a patient in need thereof at least one compound chosen from lurasidone and a pharmaceutically acceptable salt thereof without an increase of daytime sleepiness.
A kit for treatment and/or prevention of at least one CNS disorder comprising at least two compartments, and further comprising
- in a first compartment, at least one compound chosen from lurasidone and a pharmaceutically acceptable salt thereof in a first dosage amount, and
- in a second compartment, at least one compound chosen from lurasidone and a pharmaceutically acceptable salt thereof in a second dosage amount,
- wherein the first dosage amount is administered to a patient in need thereof for a first dosage period,
- the patient is classified as an early responder or a non-responder based on a response indicator, and
- the second dosage amount is administered to the patient for a second dosage period based on the response indicator, and wherein the second dose and second dosage period improve the safety and/or efficacy of treatment with at least one compound chosen from lurasidone and a pharmaceutically acceptable salt thereof.
A kit for treatment and/or prevention of at least one CNS disorder comprising at least two compartments, a first compartment and a second compartment, wherein the first compartment contains lurasidone or a pharmaceutically acceptable salt thereof in a first dosage amount, and the second compartment contains lurasidone or a pharmaceutically acceptable salt thereof in a second dosage amount.
At least one compound chosen from lurasidone or a pharmaceutically acceptable salt thereof for treating at least one CNS disorder chosen from bipolar disorder and mixed depression.
A pharmaceutical product for treating at least one CNS disorder chosen from bipolar disorder and mixed depression which comprises at least one compound chosen from lurasidone or a pharmaceutically acceptable salt thereof.
Use of at least one compound chosen from lurasidone or a pharmaceutically acceptable salt thereof in the manufacture of a medicament for treating at least one CNS disorder chosen from bipolar disorder and mixed depression.
At least one compound chosen from lurasidone or a pharmaceutically acceptable salt thereof for improving cognitive impairment in a patient having at least one CNS disorder.
A pharmaceutical product for improving cognitive impairment in a patient having at least one CNS disorder which comprises at least one compound chosen from lurasidone or a pharmaceutically acceptable salt thereof.
Use of at least one compound chosen from lurasidone or a pharmaceutically acceptable salt thereof in the manufacture of a medicament for improving cognitive impairment in a patient having at least one CNS disorder.
At least one compound chosen from lurasidone or a pharmaceutically acceptable salt thereof for treating at least one CNS disorder without an increase of daytime sleepiness.
A pharmaceutical product for treating at least one CNS disorder without an increase in daytime sleepiness which comprises at least one compound chosen from lurasidone or a pharmaceutically acceptable salt thereof.
Use of at least one compound chosen from lurasidone or a pharmaceutically acceptable salt thereof in the manufacture of a medicament for treating at least one CNS disorder without an increase in daytime sleepiness.
A titration package for optimizing efficacy and/or tolerability of lurasidone, the package comprising (i) a 20 mg/day dose of lurasidone hydrochloride for days 1, 2, and 3, (ii) a 40 mg/day dose of lurasidone hydrochloride for days 4, 5, and 6, and (iii) a 60 mg/day dose of lurasidone hydrochloride for day 7.
A titration package for optimizing efficacy and/or tolerability of lurasidone, the package comprising (i) a 20 mg/day dose of lurasidone hydrochloride for days 1 and 2, (ii) a. 40 mg/day dose of lurasidone hydrochloride for days 3 and 4, (iii) a 60 mg/day dose of lurasidone hydrochloride for days 5 and 6, and (iv) a 80 mg dose of lurasidone hydrochloride for day 7.
Dependencies are inferred from the claim text.