Claims for Patent: 11,400,087

Summary for Patent: 11,400,087

Title:	Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Abstract:	The disclosed embodiments relate to methods of initiating aripiprazole treatment in a patient who is a CYP2D6 poor metabolizer or a CYP3A4 poor metabolizer, or both.
Inventor(s):	Raoufinia; Arash (Vienna, VA)
Assignee:	Otsuka Pharmaceutical Co., Ltd. (Rockville, MD)
Application Number:	17/304,606
Patent Claims:	1. A method of treating schizophrenia or bipolar I disorder in a patient comprising: intramuscularly administering to the patient a long-acting suspension of an adjusted dose of aripiprazole of about 300 mg and co-administering to the patient an oral antipsychotic after a first administration of said adjusted dose of the long-acting suspension, wherein the dose is systemically released over a period of about one month and the patient is a CYP2D6 poor metabolizer. 2. The method according to claim 1, wherein the oral antipsychotic is administered at least for 14 days after the first administration of the adjusted dose of the long-acting suspension. 3. The method according to claim 1, wherein the oral antipsychotic is 10 mg or 20 mg per day of aripiprazole. 4. The method according to claim 1, wherein the co-administration of the oral antipsychotic helps achieving a steady state level of aripiprazole after the first administration of the adjusted dose. 5. The method according to claim 1, wherein the step of intramuscularly administering is in the patient's deltoid or gluteal muscle. 6. The method according to claim 1, wherein a long-acting suspension comprises the adjusted dose of aripiprazole, a solvent for injection, and a vehicle for aripiprazole. 7. The method according to claim 6, wherein the vehicle for aripiprazole comprises one or more of at least one suspending agent, at least one bulking agent, at least one buffer, and at least one pH adjusting agent. 8. The method according to claim 7, wherein the suspending agent is carboxymethyl cellulose sodium and the bulking agent is mannitol. 9. The method according to claim 1, wherein the aripiprazole has a mean particle size of about 1 to about 30 microns. 10. A method of treating schizophrenia or bipolar I disorder in a patient comprising: intramuscularly administering to the patient a long-acting suspension of an adjusted dose of aripiprazole of about 300 mg and co-administering to the patient an oral antipsychotic after a first administration of said adjusted dose of the long-acting suspension, wherein the dose is systemically released over a period of about one month, the patient is a CYP2D6 poor metabolizer, the oral antipsychotic is administered at least for 14 days after the first administration of the adjusted dose of the long-acting suspension, the oral antipsychotic is 10 mg or 20 mg of aripiprazole, and the step of intramuscularly administering is in the patient's deltoid or gluteal muscle. 11. The method according to claim 10, wherein a long-acting suspension comprises the adjusted dose of aripiprazole, a solvent for injection, and a vehicle for aripiprazole. 12. The method according to claim 11, the vehicle for aripiprazole comprises one or more of at least one suspending agent, at least one bulking agent, at least one buffer, and at least one pH adjusting agent. 13. The method according to claim 12, wherein the co-administration of the oral antipsychotic helps achieving a steady state level of aripiprazole after the first administration of the adjusted dose. 14. The method according to claim 13, wherein the suspending agent is carboxymethyl cellulose sodium and the bulking agent is mannitol. 15. The method according to claim 14, wherein the aripiprazole has a mean particle size of about 1 to about 30 microns. 16. A method of treating schizophrenia or bipolar I disorder in a patient comprising: intramuscularly administering to the patient a long-acting suspension of an adjusted dose of aripiprazole of 300 mg or 200 mg and co-administering to the patient an oral antipsychotic after a first administration of said adjusted dose of the long acting suspension, wherein the dose is systemically released over a period of about one month, and the patient has concomitant use of a strong CYP2D6 or CYP3A4 inhibitor. 17. The method according to claim 16, wherein the oral antipsychotic is administered at least for 14 days after the first administration of the adjusted dose of the long-acting suspension. 18. The method according to claim 16, wherein the oral antipsychotic is 10 mg or 20 mg per day of aripiprazole. 19. The method according to claim 16, wherein the co-administration of the oral antipsychotic helps achieving a steady state level of aripiprazole after the first administration of the adjusted dose. 20. The method according to claim 16, wherein the step of intramuscularly administering is in the patient's deltoid or gluteal muscle. 21. The method according to claim 16, wherein a long-acting suspension comprises the adjusted dose of aripiprazole, a solvent for injection, and a vehicle for aripiprazole. 22. The method according to claim 21, wherein the vehicle for aripiprazole comprises one or more of at least one suspending agent, at least one bulking agent, at least one buffer, and at least one pH adjusting agent. 23. The method according to claim 22, wherein the suspending agent is carboxymethyl cellulose sodium and the bulking agent is mannitol. 24. The method according to claim 16, wherein the aripiprazole has a mean particle size of about 1 to about 30 microns. 25. A method of treating schizophrenia or bipolar I disorder in a patient comprising: intramuscularly administering to the patient a long-acting suspension of an adjusted dose of aripiprazole of 300 mg or 200 mg and co-administering to the patient an oral antipsychotic after a first administration of said adjusted dose of the long acting suspension, wherein the dose is systemically released over a period of about one month, the patient has concomitant use of a strong CYP2D6 or CYP3A4 inhibitor, the oral antipsychotic is administered at least for 14 days after the first administration of the adjusted dose of the long-acting suspension, the oral antipsychotic is 10 mg or 20 mg of aripiprazole, and the step of intramuscularly administering is in the patient's deltoid or gluteal muscle. 26. The method according to claim 25, wherein a long-acting suspension comprises the adjusted dose of aripiprazole, a solvent for injection, and a vehicle for aripiprazole. 27. The method according to claim 26, the vehicle for aripiprazole comprises one or more of at least one suspending agent, at least one bulking agent, at least one buffer, and at least one pH adjusting agent. 28. The method according to claim 27, wherein the co-administration of the oral antipsychotic helps achieving a steady state level of aripiprazole after the first administration of the adjusted dose. 29. The method according to claim 28, wherein the suspending agent is carboxymethyl cellulose sodium and the bulking agent is mannitol. 30. The method according to claim 29, wherein the aripiprazole has a mean particle size of about 1 to about 30 microns.