Claims for Patent: 11,273,158

Summary for Patent: 11,273,158

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):	von Moltke; Lisa L. (Newton, MA), Weiden; Peter J. (Newton, MA), Hard; Marjie L. (Lexington, MA)
Assignee:	Alkermes Pharma Ireland Limited (Dublin, IE)
Application Number:	16/291,768
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 AL.sub.NCD; and a third component comprising a therapeutically effective amount of aripiprazole lauroxil; wherein all components of the method are administered at substantially the same time. 2. The method of claim 1, wherein the AL.sub.NCD of the second component comprises polysorbate 20, sodium citrate, sodium chloride, an aqueous buffer, and a population of particles of aripiprazole lauroxil. 3. The method of claim 2, wherein the population of particles of aripiprazole lauroxil of the second component has a volume-based particle distribution size (Dv50) between about 175 nm and about 350 nm. 4. The method of claim 2, wherein the AL.sub.NCD has a ratio of particles to polysorbate 20 of 17:1. 5. The method of claim 1, wherein the first component is administered at a dosage of about 30 mg. 6. The method of claim 1, wherein the second component is administered at a dosage of about 675 mg of the active component. 7. The method of claim 1, wherein the third component is administered at a dosage of about 300-1500 mg. 8. The method of claim 1, wherein the third component is administered at a dosage of 441, 662, 882, or 1064 mg. 9. 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, and wherein the first component is not administered again within 21 days of the initial administration. 10. 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. 11. The method of claim 1, wherein the first component is only administered once during the treatment duration. 12. The method of claim 1, wherein the first component is not administered again within 21 days following the initial treatment. 13. The method of claim 1, wherein the first component is only administered on the first and second day of treatment. 14. The method of claim 1, wherein the first component is only administered on the first day of treatment. 15. 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 AL.sub.NCD; 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 all components of the method are administered at substantially the same time. 16. The method of claim 15, wherein the therapeutically effective mean blood plasma level of aripiprazole is about 102-435 ng/mL at steady-state plasma level. 17. The method of claim 15, wherein the AL.sub.NCD of the second component comprises polysorbate 20, sodium citrate, sodium chloride, an aqueous buffer, and a population of particles of aripiprazole lauroxil. 18. The method of claim 17, wherein the population of particles of aripiprazole lauroxil of the second component have a volume-based particle distribution size (Dv50) between about 175 nm and about 350 nm. 19. The method of claim 17, wherein the AL.sub.NCD has a ratio of particles to polysorbate 20 of 17:1. 20. The method of claim 15, wherein the therapeutically effective mean blood plasma level of aripiprazole is reached within 24 hours of the initial treatment. 21. The method of claim 15, wherein the therapeutically effective mean blood plasma level of aripiprazole is maintained for no less than 21 days. 22. The method of claim 15, wherein the method comprises a regimen wherein the first, second, and third components are administered at substantially the same time, and wherein the first component is not administered again within 21 days of the initial administration. 23. The method of claim 15, 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. 24. The method of claim 15, wherein the first component is only administered once during the treatment duration. 25. The method of claim 15, wherein the first component is not administered again within 21 days following the initial treatment. 26. The method of claim 15, wherein the first component is only administered on the first and second day of treatment. 27. The method of claim 15, wherein the first component is only administered on the first day of treatment. 28. The method of claim 1, wherein the first component comprises about 30 mg of aripiprazole; the second component comprises about 629-695 mg of AL.sub.NCD; and the third component comprises about 662 mg of aripiprazole lauroxil; and wherein the method comprises a regimen wherein the first component is administered once within the first 21 days of the regimen.