Claims for Patent: 11,344,547

Summary for Patent: 11,344,547

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:	17/459,221
Patent Claims:	1. A method of treating schizophrenia or bipolar I disorder in a patient comprising: intramuscularly administering to a patient a long-acting suspension of an adjusted dose of aripiprazole of 200 mg or 300 mg, wherein the dose is released over a period of about one month, the patient is concomitantly administered a strong CYP2D6 or CYP3A4 inhibitor, and administering of the long-acting suspension is avoided when the patient is taking a CYP3A4 inducer. 2. The method according to claim 1, wherein the step of intramuscularly administering is in the patient's deltoid or gluteal muscle. 3. 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. 4. The method according to claim 3, 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. 5. The method according to claim 4, wherein the suspending agent is carboxymethyl cellulose sodium and the bulking agent is mannitol. 6. The method according to claim 1, wherein aripiprazole has a mean particle size ranging from about 1 to about 30 microns. 7. A method of treating schizophrenia or bipolar I disorder in a patient comprising: intramuscularly administering to a patient a long-acting suspension of an adjusted dose of aripiprazole and co-administering to a patient an oral antipsychotic after a first administration of the adjusted dose of the long-acting suspension, wherein the adjusted dose is 300 mg or 200 mg when the patient is taking a strong CYP2D6 or CYP3A4 inhibitor, the adjusted dose is 200 mg or 160 mg when the patient is taking a CYP2D6 and CYP3A4 inhibitor, and administering of the long-acting suspension is avoided when the patient is taking a CYP3A4 inducer. 8. The method according to claim 7, wherein the adjusted dose is 300 mg or 200 mg when the patient is taking a strong CYP2D6 or CYP3A4 inhibitor for 14 days or more. 9. The method according to claim 7, wherein the oral antipsychotic is administered at least for 14 days after the first administration of the adjusted dose of the long-acting suspension. 10. The method according to claim 9, wherein the oral antipsychotic is 10 mg or 20 mg per day of aripiprazole. 11. The method according to claim 7, wherein the co-administration of the oral antipsychotic helps achieve a steady state level of aripiprazole after the first administration of the adjusted dose. 12. The method according to claim 7, wherein a long-acting suspension comprises the adjusted dose of aripiprazole, a solvent for injection, and a vehicle for aripiprazole. 13. The method according to claim 12, 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. 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 7, wherein aripiprazole has a mean particle size ranging from about 1 to about 30 microns. 16. A method of treating schizophrenia or bipolar I disorder in a patient comprising: intramuscularly administering a long-acting suspension of a dose of aripiprazole of about 300 mg or 400 mg and co-administering an oral antipsychotic after a first administration of the dose of the long-acting suspension to a patient taking a CYP3A4 inducer, wherein use of the CYP3A4 inducer is avoided after an administration of the long-acting suspension. 17. The method according to claim 16, wherein the oral antipsychotic is administered at least for 14 days after the first administration of the dose of the long-acting suspension. 18. The method according to claim 17, 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 achieve a steady state level of aripiprazole after the first administration of the 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 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 21, wherein the suspending agent is carboxymethyl cellulose sodium and the bulking agent is mannitol. 24. The method according to claim 16, wherein aripiprazole has a mean particle size ranging from about 1 to about 30 microns.