Claims for Patent: 10,980,803

Summary for Patent: 10,980,803

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:	16/710,495
Patent Claims:	1. A method of treating schizophrenia in a patient comprising: intramuscularly administering to the patient a long-acting suspension of an adjusted dose of aripiprazole of about 300 mg or of aripiprazole prodrug of about 441 mg, wherein the dose is systemically released over a period of about one month, and the patient is a CYP2D6 poor metabolizer. 2. The method of claim 1, wherein the step of intramuscularly administering is in the patient's deltoid or gluteal muscle. 3. The method of claim 2, wherein the gluteal muscle is chosen from ventrogluteal muscle and dorsogluteal muscle. 4. The method of claim 1, wherein the aripiprazole prodrug is 7-(4-(4-(2,3-dichlorophenyl)piperazin-l-yl)butoxy)-2-oxo-3,4-dihydroquino- lin-l(2H)-yl)methyl dodecanoate. 5. The method of claim 1, wherein the patient is not concomitantly administered a strong CYP3A4 inhibitor or a strong CYP2D6 inhibitor. 6. A method of treating schizophrenia in a patient comprising: intramuscularly administering to the patient a long-acting suspension of an adjusted dose of aripiprazole of 200 mg, wherein the dose is systemically released over a period of about one month and the patient is a CYP2D6 poor metabolizer concomitantly taking a CYP3A4 inhibitor. 7. The method of claim 6, wherein the step of intramuscularly administering is in the patient's deltoid or gluteal muscle. 8. The method of claim 7, wherein the gluteal muscle is chosen from ventrogluteal muscle and dorsogluteal muscle. 9. A method of treating schizophrenia in a patient comprising: intramuscularly administering to the patient a long-acting suspension of an adjusted dose of aripiprazole of 300 mg or of aripiprazole prodrug of 441 mg, 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 and where an initial recommended dose for a patient with normal CYP2D6 or CYP3A4 enzyme function is 400 mg of aripiprazole or 662 mg of aripiprazole prodrug. 10. The method of claim 9, wherein the patient is a CYP2D6 and CYP3A4 extensive metabolizer. 11. The method of claim 9, wherein the patient's concomitant use of a strong CYP2D6 inhibitor or a strong CYP3A4 inhibitor is for at least 14 days. 12. The method of claim 9, wherein the step of intramuscularly administering is in the patient's deltoid or gluteal muscle. 13. The method of claim 11, wherein the gluteal muscle is chosen from ventrogluteal muscle and dorsogluteal muscle. 14. A method of treating schizophrenia in a patient comprising: intramuscularly administering to the patient a long-acting suspension of an adjusted dose of aripiprazole of 200 mg, wherein the patient has concomitant use of CYP2D6 and CYP3A4 inhibitors, where an initial recommended dose for a patient with normal CYP2D6 or CYP3A4 enzyme function is 400 mg, and the dose is systemically released over a period of about one month. 15. The method of claim 14, wherein the patient's concomitant use of CYP2D6 and a CYP3A4 inhibitors is for at least 14 days. 16. The method of claim 14, wherein the patient is a CYP2D6 and CYP3A4 extensive metabolizer. 17. The method of claim 14, wherein the step of intramuscularly administering is in the patient's deltoid or gluteal muscle. 18. The method of claim 17, wherein the gluteal muscle is chosen from ventrogluteal muscle and dorsogluteal muscle. 19. A method of treating schizophrenia in a patient comprising: intramuscularly administering to the patient a long-acting suspension of an adjusted dose of aripiprazole of 198 mg, wherein the patient has concomitant use of a strong CYP2D6 or CYP3A4 inhibitor, where an initial recommended dose for a patient with normal CYP2D6 or CYP3A4 enzyme function is 300 mg, and the dose is systemically released over a period of about one month. 20. The method of claim 19, wherein the patient's concomitant use of a strong CYP2D6 or CYP3A4 inhibitor is for at least 14 days. 21. The method of claim 19, wherein the step of intramuscularly administering is in the patient's deltoid or gluteal muscle. 22. The method of claim 21, wherein the gluteal muscle is chosen from ventrogluteal muscle and dorsogluteal muscle. 23. A method of treating schizophrenia in a patient comprising: intramuscularly administering to the patient a long-acting suspension of an adjusted dose of aripiprazole of 159 mg, wherein the patient has concomitant use of CYP2D6 and CYP3A4 inhibitors, where an initial recommended dose for a patient with normal CYP2D6 or CYP3A4 enzyme function is 300 mg of aripiprazole, and the dose is systemically released over a period of about one month. 24. The method of claim 23, wherein the patient's concomitant use of CYP2D6 and CYP3A4 inhibitors is for at least 14 days. 25. The method of claim 23, wherein the step of intramuscularly administering is in the patient's deltoid or gluteal muscle. 26. The method of claim 25, wherein the gluteal muscle is chosen from ventrogluteal muscle and dorsogluteal muscle.