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1. WO2020132310 - DEXTROAMPHETAMINE AND LISDEXAMFETAMINE TO REVERSE DEXMEDETOMIDINE SEDATION

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[ EN ]

WHAT IS CLAIMED IS:

1. A pharmaceutical composition comprising dextroamphetamine, or a pharmaceutically acceptable salt thereof, and lisdexamfetamine, or a pharmaceutically acceptable salt thereof, optionally wherein the dextroamphetamine and lisdextroamfetamine are present in a ratio of at least 1: 1 up to 1:20, preferably 1 :2 to 1 :20, 1 :5 to 1 :20, or 1 :8 to 1: 12.

2. The pharmaceutical composition of claim 1, wherein the composition further comprises one or more pharmaceutically acceptable excipients.

3. The pharmaceutical composition of any one of claims 1 or 2, wherein the active agents consist of dextroamphetamine, or a pharmaceutically acceptable salt thereof, and lisdexamfetamine, or a pharmaceutically acceptable salt thereof.

4. The pharmaceutical composition of any one of claims 1 or 2, wherein the pharmaceutical composition is a liquid formulation.

5. The pharmaceutical composition of claim 4, wherein the composition is formulated for intravenous administration.

6. The pharmaceutical composition of any one of claims 1 or 2, which is lyophilized.

7. A method for reversing dexmedotomidine sedation or facilitating emergence from

dexmedotomidine sedation in a subject, the method comprising administering, preferably intravenously, to a subject in need thereof an effective amount of a pharmaceutical composition comprising dextroamphetamine, or a pharmaceutically acceptable salt thereof; lisdexamfetamine, or a pharmaceutically acceptable salt thereof; or a combination thereof, optionally wherein the dextroamphetamine and lisdextroamfetamine are administered in a ratio of 1 :2 to 1 :20, 1 :5 to 1 :20, or 1 : 8 to 1: 12.

8. The method of claim 7, wherein the reversal of dexmedotomidine sedation comprises one or more of increased mobility in the subject; restoration of a low-amplitude, high- frequency awake pattern on an electroencephalogram; increased consciousness in the subject; reversal of bradycardia; or recovery from hypotension, preferably a return to normotension.

9. The method of any one of claims 7-8, wherein the subject has been, but is no longer being, administered dexmedotomidine.

10. The method of any one of claims 7-8, wherein the subject is administered the

pharmaceutical composition comprising dextroamphetamine, or a pharmaceutically acceptable salt thereof, lisdexamfetamine, or a pharmaceutically acceptable salt thereof, or a combination thereof, immediately prior to, or immediately subsequent to, cessation of the administration of dexmedotomidine.

11. The method of any one of claims 7-10, wherein the pharmaceutical composition

comprises dextroamphetamine, or a pharmaceutically acceptable salt thereof.

12. The method of claim 11, wherein dextroamphetamine, or a pharmaceutically acceptable salt thereof, is the only active agent in the composition.

13. The method of any one of claims 7-10, wherein the pharmaceutical composition

comprises lisdexamfetamine, or a pharmaceutically acceptable salt thereof.

14. The method of claim 13, wherein lisdexamfetamine, or a pharmaceutically acceptable salt thereof, is the only active agent in the composition.

15. The method of any one of claims 7-10, wherein the pharmaceutical composition

comprises dextroamphetamine, or a pharmaceutically acceptable salt thereof, and lisdexamfetamine, or a pharmaceutically acceptable salt thereof.

16. The method of claim 15, wherein dextroamphetamine, or a pharmaceutically acceptable salt thereof, and lisdexamfetamine, or a pharmaceutically acceptable salt thereof, are the only active agents in the composition, optionally wherein the dextroamphetamine and lisdextroamfetamine are present in a ratio of 1 :2 to 1:20, 1:5 to 1:20, or 1:8 to 1: 12.

17. The method of any one of claims claim 7-16, wherein the composition further comprises one or more pharmaceutically acceptable excipients.

18. The method of any one of claims 7-17, wherein the subject is a mammal.

19. The method of claim 18, wherein the subject is a human or veterinary subject.

20. A pharmaceutical composition comprising:

(i) dextroamphetamine, or a pharmaceutically acceptable salt thereof;

(ii) lisdexamfetamine, or a pharmaceutically acceptable salt thereof; or

(iii) a combination thereof, optionally wherein the dextroamphetamine and

lisdextroamfetamine are present in a single composition in a ratio of 1 :2 to 1 :20, 1 :5 to 1 :20, or 1 :8 to 1 : 12,

for use in reversing dexmedotomidine sedation or facilitating emergence from

dexmedotomidine sedation in a subject.

21. The pharmaceutical composition for the use of claim 20, wherein the composition further comprises one or more pharmaceutically acceptable excipients.

22. The pharmaceutical composition for the use of any one of claims 20 or 21, wherein the active agents consist of dextroamphetamine, or a pharmaceutically acceptable salt thereof, and lisdexamfetamine, or a pharmaceutically acceptable salt thereof.

23. The pharmaceutical composition for the use of any one of claims 20 or 21, wherein the pharmaceutical composition is a liquid formulation.

24. The pharmaceutical composition for the use of any one of claims 20 or 21, wherein the composition is formulated for intravenous administration.

25. The pharmaceutical composition for the use of any one of claims 20 or 21, which is

lyophilized.

26. The pharmaceutical composition for the use of any one of claims 20 or 21, wherein the pharmaceutical composition comprises dextroamphetamine and lisdextroamfetamine in a ratio of 1 :2 to 1 :20, 1 :5 to 1:20, or 1:8 to 1: 12.

27. The pharmaceutical composition of claim 1, wherein the dextroamphetamine and

lisdextroamfetamine are present in a ratio of 1 :2 to 1 :20, 1 :5 to 1 :20, or 1 : 8 to 1 : 12.

28. The method of any one of claims 7-8, wherein the dextroamphetamine and

lisdextroamfetamine are administered in a ratio of 1:2 to 1:20, 1:5 to 1:20, or 1 :8 to 1 : 12.