Claims for Patent: 10,369,143

Summary for Patent: 10,369,143

Title:	Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation
Abstract:	Provided herein is a method of treating a central nervous system disorder in a patient in need thereof, wherein the central nervous system disorder is selected from schizophrenia, Alzheimer's disease, Huntington's disease, Parkinson's disease, and Lewy Body dementia. The method comprises orally administering an initial dose of between 75 mg and 300 mg xanomeline and an initial dose of between 20 mg and 200 mg trospium chloride to the patient during a 24-hour period. Provided that the patient tolerates said administration, an increased dose of trospium chloride and an increased dose of xanomeline are orally administering to the patient, wherein the increased dose of trospium chloride is greater than the initial dose of the trospium chloride, and wherein the increased dose of xanomeline is greater than the initial dose of the xanomeline.
Inventor(s):	Eric Elenko, Philip E. Murray, III, Andrew C. Miller
Assignee:	Puretech Health LLC , Puretech Management Inc
Application Number:	US16/270,206
Patent Claims:	1. A method of treating a central nervous system disorder in a patient in need thereof, wherein the central nervous system disorder is selected from schizophrenia, Alzheimer's disease, Huntington's disease, Parkinson's disease, and Lewy Body dementia, the method comprising: orally administering an initial dose of between 75 mg and 300 mg xanomeline and/or a salt thereof and an initial dose of between 20 mg and 200 mg trospium chloride to the patient during a 24-hour period, wherein the initial dose of trospium chloride is in an amount effective to reduce a side effect associated with the initial dose of xanomeline and/or the salt thereof; and orally administering to the patient an increased dose of trospium chloride and an increased dose of xanomeline and/or the salt thereof, wherein the increased dose of trospium chloride is greater than the initial dose of the trospium chloride, and wherein the increased dose of xanomeline and/or the salt thereof is greater than the initial dose of the xanomeline and/or the salt thereof. 2. The method of claim 1, wherein the central nervous system disorder is schizophrenia. 3. The method of claim 1, wherein the central nervous system disorder is Alzheimer's disease. 4. The method of claim 1, wherein the central nervous system disorder is Huntington's disease. 5. The method of claim 1, wherein the central nervous system disorder is Parkinson's disease. 6. The method of claim 1, wherein the central nervous system disorder is Lewy Body dementia. 7. The method of claim 1, wherein the initial dose of xanomeline and/or the salt thereof and the initial dose of trospium chloride are in the same dosage vehicle. 8. The method of claim 1, wherein the initial dose of xanomeline and/or the salt thereof and the initial dose of trospium chloride are in different dosage vehicles. 9. The method of claim 1, wherein the increased dose of xanomeline and/or the salt thereof and the increased dose of trospium chloride are in the same dosage vehicle. 10. The method of claim 1, wherein the increased dose of xanomeline and/or the salt thereof and the increased dose of trospium chloride are in different dosage vehicles. 11. The method of claim 1, wherein the initial dose of trospium chloride is administered to the patient two times during the 24-hour period. 12. The method of claim 1, wherein the increased dose of trospium chloride is administered to the patient two times during the 24-hour period. 13. The method of claim 1, wherein the initial dose of trospium chloride is between 20 mg and 60 mg administered to the patient during the 24-hour period. 14. The method of claim 1, wherein the initial dose of trospium chloride is between 60 mg and 200 mg administered to the patient during the 24-hour period. 15. The method of claim 1, wherein the increased dose of trospium chloride is between 20 mg and 200 mg administered to the patient during the 24-hour period. 16. The method of claim 1, wherein the increased dose of trospium chloride is between 20 mg and 60 mg administered to the patient during the 24-hour period. 17. The method of claim 1, wherein the increased dose of trospium chloride is between 60 mg and 200 mg administered to the patient during the 24-hour period. 18. The method of claim 1, wherein the initial dose of xanomeline and/or the salt thereof is between 75 mg and 225 mg administered to the patient during the 24-hour period and the initial dose of trospium chloride is between 20 mg and 60 mg administered to the patient during the 24-hour period. 19. The method of claim 1, wherein the increased dose of xanomeline and/or the salt thereof is between 75 mg and 225 mg administered to the patient during the 24-hour period and the increased dose of trospium chloride is between 20 mg and 60 mg administered to the patient during the 24-hour period. 20. The method of claim 1, wherein the initial dose of xanomeline and/or the salt thereof is 300 mg administered to the patient during a 24-hour period and the initial dose of trospium chloride is between 60 mg and 200 mg administered to the patient during a 24-hour period. 21. The method of claim 1, wherein the increased dose of xanomeline and/or the salt thereof is 300 mg administered to the patient during a 24-hour period and the increased dose of trospium chloride is between 60 mg and 200 mg administered to the patient during a 24-hour period. 22. The method of claim 1, wherein after the initial dose of xanomeline and the initial dose of trospium chloride are administered, the method further comprises orally administering an intermediate dose of between 75 mg and 300 mg xanomeline and/or the salt thereof and the initial dose of between 20 mg and 200 mg trospium chloride to the patient during a 24-hour period, wherein the intermediate dose of xanomeline is greater than the initial dose of the xanomeline and less than the increased dose of xanomeline and/or the salt thereof. 23. The method of claim 1, wherein the salt of xanomeline is the salt of tartaric acid.