Claims for Patent: 12,251,381

Summary for Patent: 12,251,381

Title:	Aripiprazole dosing strategy
Abstract:	The present invention relates to methods of treating schizophrenia using a combination of aripiprazole, aripiprazole lauroxil, and a nanoparticle dispersion of aripiprazole lauroxil.
Inventor(s):	Lisa L. von Moltke, Peter J. Weiden, Marjie L. Hard
Assignee:	Alkermes Pharma Ireland Ltd
Application Number:	US17/665,015
Patent Claims:	1. A method of treating schizophrenia in a subject in need thereof, the method comprising administering to the subject: a first component comprising about 5-50 mg of aripiprazole; a second component comprising about 629-695 mg of ALNCD having a volume-based particle distribution size (Dv50) between about 175 nm and about 350 nm; and a third component comprising a therapeutically effective amount of aripiprazole lauroxil; wherein the method comprises a regimen wherein the first component is only administered on the first and/or second days of treatment, the second component is only administered on the first day of treatment, and the third component is only administered once within the first 10 days of treatment. 2. The method of claim 1, wherein the ALNCD comprises polysorbate 20, sodium citrate, sodium chloride, an aqueous buffer, and a population of particles of aripiprazole lauroxil, wherein the ALNCD has a ratio of particles to polysorbate 20 of between about 0.1:1 and about 40:1. 3. The method of claim 1, wherein the first component is administered at a dosage of about 30 mg or about 15 mg. 4. The method of claim 1, wherein the second component is administered at a dosage of about 675 mg of ALNCD. 5. The method of claim 1, wherein the third component is administered at a dosage of about 300-1500 mg. 6. The method of claim 1, wherein the third component is administered at a dosage of 441, 662, 882, or 1064 mg. 7. The method of claim 1, wherein the method comprises a regimen wherein the first, second, and third components are administered at substantially the same time, followed by a second treatment comprising administering the third component alone. 8. The method of claim 7, wherein the second treatment occurs no earlier than 21 days after the initial treatment. 9. The method of claim 1, wherein the first component is only administered once during the treatment duration. 10. The method of claim 1, wherein the first component is not administered again within 21 days following the initial treatment. 11. The method of claim 9, wherein the third component is administered on the first or second day of treatment. 12. The method of claim 9, wherein the third component is administered 7-10 days after the start of the treatment regimen. 13. The method of claim 9, wherein the first component is only administered on the first day of treatment. 14. The method of claim 1, wherein the first component is administered orally. 15. The method of claim 1, wherein the second component and third component are administered intra-muscularly to the deltoid or gluteus. 16. A method of treating schizophrenia in a subject in need thereof, the method comprising administering to the subject: a first component comprising aripiprazole; a second component comprising ALNCD having a volume-based particle distribution size (Dv50) between about 175 nm and about 350 nm; and a third component comprising aripiprazole lauroxil; wherein the dosages of the first, second, and third components combined are sufficient to maintain a therapeutically effective mean blood plasma level of aripiprazole in the subject; and wherein the method comprises a regimen wherein the first component is only administered on the first and/or second days of treatment, the second component is only administered on the first day of treatment, and the third component is only administered once within the first 10 days of treatment. 17. The method of claim 16, wherein the ALNCD comprises polysorbate 20, sodium citrate, sodium chloride, an aqueous buffer, and a population of particles of aripiprazole lauroxil, wherein the ALNCD has a ratio of particles to polysorbate 20 of between about 0.1:1 and about 40:1. 18. The method of claim 16, wherein the therapeutically effective mean blood plasma level of aripiprazole is reached within 24 hours of the initial treatment. 19. The method of claim 16, wherein the therapeutically effective mean blood plasma level of aripiprazole is maintained for no less than 21 days. 20. The method of claim 16, wherein the first component is only administered once during the treatment duration. 21. The method of claim 16, wherein the first component is not administered again within 21 days following the initial treatment. 22. The method of claim 16, wherein the regimen further comprises a second administration of the third component alone. 23. The method of claim 16, wherein the third component is administered on the first or second day of treatment. 24. The method of claim 16, wherein the third component is administered 7-10 days after the start of the treatment regimen. 25. The method of claim 16, wherein the first component is only administered on the first day of treatment. 26. The method of claim 16, wherein the first component is administered orally. 27. The method of claim 16, wherein the second component and third component are administered intra-muscularly to the deltoid or gluteus.