Claims for Patent: 11,648,244

Summary for Patent: 11,648,244

Title:	Methods for the treatment of abnormal involuntary movement disorders
Abstract:	Disclosed herein are new dosage regimens for deuterium-substituted benzoquinoline compounds, and methods for the treatment of abnormal muscular activity, movement disorders, and related conditions.
Inventor(s):	David Stamler, Michael Fangching HUANG
Assignee:	Auspex Pharmaceuticals Inc
Application Number:	US15/667,483
Patent Claims:	1. A method of treating abnormal involuntary movements in a human subject having Tardive Dyskinesia; wherein the subject is sixty years of age or older, and has a history of dopamine receptor antagonist use for at least one month; or wherein the subject is not sixty years of age or older, and has a history of dopamine receptor antagonist use for at least three months; comprising: administering to the subject, in one or two doses, a total daily amount of deutetrabenazine of from about 24 mg to about 48 mg; wherein the administration results in an improvement in motor function in the subject, as compared to the subject's motor function prior to the administration, and no clinically significant adverse event. 2. The method of claim 1, wherein the total daily amount of deutetrabenazine is 24 mg. 3. The method of claim 1, wherein the total daily amount of deutetrabenazine is 42 mg. 4. The method of claim 1, wherein the total daily amount of deutetrabenazine is 36 mg. 5. The method of claim 1, wherein the total daily amount of deutetrabenazine is administered in two doses. 6. The method of claim 1, wherein the improvement in motor function is a reduction in the severity of abnormal involuntary movements, as measured by the Abnormal Involuntary Movement Scale. 7. The method of claim 6, wherein the improvement is a 10% reduction in Abnormal Involuntary Movement Scale score. 8. The method of claim 6, wherein the improvement is a 50% reduction in Abnormal Involuntary Movement Scale score. 9. The method of claim 6, wherein the improvement is a 90% reduction in Abnormal Involuntary Movement Scale score. 10. The method of claim 1, wherein the improvement in motor function is measured by the Clinical Global Impression of Change or the modified Craniocervical Dystonia score. 11. The method of claim 1, resulting in no significant increase in insomnia, depression, anxiety, agitation, suicidal ideation, akathisia, irritability, fatigue, parkinsonism or dysphagia in the subject. 12. The method of claim 1, further comprising administering to the subject another therapeutic agent useful in the treatment of Tardive Dyskinesia. 13. The method of claim 1, wherein the dopamine receptor antagonist is administered concomitantly with the deutetrabenazine. 14. The method of claim 1, wherein the subject is an adult. 15. The method of claim 1, wherein the subject is at least 18 years of age. 16. The method of claim 1, wherein the total daily amount of deutetrabenazine is 30 mg. 17. The method of claim 1, wherein the total daily amount of deutetrabenazine is 48 mg. 18. The method of claim 1, wherein the total daily amount of deutetrabenazine is from about 24 mg to about 36 mg. 19. The method of claim 1, resulting in no significant increase in depression or suicidal ideation. 20. The method of claim 1, wherein the subject has an underlying psychiatric illness. 21. The method of claim 18, wherein the subject is concurrently receiving a strong CYP2D6 inhibitor. 22. The method of claim 21, wherein the strong CYP2D6 inhibitor is fluoxetine, paroxetine, bupropion, quinidine, cinacalcet, or ritonavir. 23. The method of claim 21, wherein the strong CYP2D6 inhibitor is paroxetine, fluoxetine, or bupropion.