Claims for Patent: 10,369,144

Summary for Patent: 10,369,144

Title:	Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation
Abstract:	The present disclosure provides a method of treating a central nervous system disorder in a patient in need thereof. The method comprises orally administering between 75 mg and 300 mg xanomeline and between 20 mg and 200 mg trospium chloride to the patient during a 24-hour period. The central nervous system disorder is selected from schizophrenia, Alzheimer's disease, Huntington's disease, Parkinson's disease, and Lewy Body dementia, wherein use of the trospium chloride alleviates a side effect associated with use of the xanomeline.
Inventor(s):	Eric Elenko, Philip E. Murray, III, Andrew C. Miller
Assignee:	Puretech Health LLC , Puretech Management Inc
Application Number:	US16/289,165
Patent Claims:	1. A single capsule formulation for oral administration comprising xanomeline and/or a salt thereof in an amount to cause a side effect chosen from nausea, vomiting, diarrhea, sweating and excess salivation; and trospium chloride in an amount effective to reduce the side effect associated with the oral administration of the xanomeline and/or the salt thereof. 2. The formulation of claim 1, which is formulated as an immediate release formulation. 3. The formulation of claim 1, which is formulated as a controlled release formulation. 4. The formulation of claim 1, wherein the xanomeline and/or the salt thereof is formulated as a controlled release formulation and the trospium chloride is formulated as an immediate release formulation. 5. The formulation of claim 1, wherein the formulation contains from 1 milligram to 1 gram of xanomeline and/or the salt thereof. 6. The formulation of claim 1, wherein the formulation contains from five milligrams to 700 milligrams of xanomeline and/or the salt thereof. 7. The formulation of claim 1, wherein the formulation contains from five milligrams to 500 milligrams of xanomeline and/or the salt thereof. 8. The formulation of claim 1, wherein the formulation contains from 25 milligrams to 300 milligrams of xanomeline and/or the salt thereof. 9. The formulation of claim 1, wherein the formulation contains from one milligram to 400 milligrams of trospium chloride. 10. The formulation of claim 1, wherein the formulation contains from 6.5 milligrams to 200 milligrams of trospium chloride. 11. The formulation of claim 1, wherein the formulation contains 20 milligrams of trospium chloride. 12. A method of treating schizophrenia in a patient in need thereof, the method comprising: orally administering a single capsule formulation of claim 1 twice daily. 13. The method of claim 12, wherein the formulation contains 20 milligrams of trospium chloride. 14. The method of claim 12, wherein the formulation contains from 25 milligrams to 300 milligrams of xanomeline and/or the salt thereof. 15. The formulation of claim 1, wherein the salt of xanomeline is the salt of tartaric acid. 16. The formulation of claim 1, wherein the amount of the xanomeline and/or the salt thereof is effective to treat a central nervous system disorder chosen from Alzheimer's disease, Huntington's disease, Parkinson's disease, and Lewy Body dementia.