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1. WO2020006119 - METHODS FOR TREATING AGITATION USING DEXMEDETOMIDINE HYDROCHLORIDE

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Claims

1. A method for treating agitation or signs of agitation in a human subject who is alert prior to treatment, comprising administering dexmedetomidine hydrochloride intravenously to the subject at a cumulative dose of about 0.1 mcg/kg to about 1 mcg/kg to achieve the desired anti agitation effect.

2. A method for treating agitation or signs of agitation in a human subject who is alert prior to treatment, comprising administering dexmedetomidine hydrochloride intravenously to the subject to a total dose in a range from about 2 meg to about 100 meg to achieve the desired anti agitation effect.

3. The method according to claim 1 or claim 2 for the treatment of acute agitation.

4. The method according to any preceding claim, wherein the agitation or signs of agitation are associated with senile dementia of the Alzheimer’s type (SDAT), Alzheimer’s disease, schizophrenia, opioid withdrawal disorder , bipolar disorder, or hyperactive delirium.

5. The method according to claim 4, wherein the agitation or signs of agitation is associated with senile dementia of the Alzheimer type (SDAT).

6. The method according to claim 4, wherein the agitation or signs of agitation is associated with schizophrenia.

7. The method according to claim 4, wherein the agitation or signs of agitation is associated with opioid withdrawal.

8. The method according to any preceding claim, wherein the desired anti-agitation effect is achieved without also producing clinically meaningful effects on blood pressure and/or heart rate.

9. The method according to any preceding claim, wherein dexmedetomidine hydrochloride is administered intravenously as one or more discrete injections.

10. The method according to any one of claims 1 to 8, wherein dexmedetomidine hydrochloride is administered intravenously as a continuous infusion.

11. The method according to claim 10, wherein the infusion is given at a rate of about 0.1 to about 0.6 mcg/kg/hr.

12. The method according to any preceding claim, wherein the subject is between 55 to 75 years old.

13. The method according to any preceding claim, wherein agitation is reduced to a value of 7 or below 7 according to the PEC scale.

14. The method according to any preceding claim, wherein the reduction in agitation is associated with the attainment of a mild sedative effect.

15. The method according to claim 14, wherein the mild sedative effect corresponds to a RASS score of -1.

16. The method according to claim 14, wherein the mild sedative effect persists for up to about 120 minutes.

17. A method of treating agitation or signs of agitation in a human subject suffering from senile dementia of the Alzheimer’s type (SDAT) who is alert prior to treatment, comprising administering dexmedetomidine hydrochloride intravenously to the subject at a cumulative dose of about 0.15 mcg/kg to about 0.75 mcg/kg to achieve the desired anti-agitation effect, which effect persists for up to about 30 minutes after discontinuation of administration of dexmedetomidine hydrochloride, and wherein the reduction in agitation is associated with the attainment of a mild sedative effect.

18. A method of treating agitation or signs of agitation in a human subj ect suffering from senile dementia of the Alzheimer’s type (SDAT) who is alert prior to treatment, comprising administering dexmedetomidine hydrochloride intravenously to the subject at a total dose of about 5 meg to about 40 meg to achieve the desired anti-agitation effect, which effect persists for up to about 30 minutes after discontinuation of administration of dexmedetomidine hydrochloride, and wherein the reduction in agitation is associated with the attainment of a mild sedative effect.

19. The method according to claim 17 or claim 18, wherein the mild sedative effect corresponds to a RASS score of -1.

20. The method according to any one of claims 17 to 19, wherein the subject is between 55 to 75 years old.

21. The method according to any one of claims 17 to 20, wherein the desired anti-agitation effect is achieved without also producing clinically meaningful effects on blood pressure and/or heart rate.

22. The method according to any one of claims 17 to 21, wherein dexmedetomidine hydrochloride is administered intravenously as one or more discrete injections.

23. A method of treating agitation or signs of agitation in a human subject suffering from schizophrenia who is alert prior to treatment, comprising administering dexmedetomidine hydrochloride intravenously to the subject at a total dose of about 5 meg to about 40 meg to achieve the desired anti-agitation effect, wherein agitation is reduced to a value of 7 or below 7 according to the PEC scale, and wherein the reduction in agitation is associated with the attainment of a mild sedative effect.

24. The method according to claim 23, wherein the mild sedative effect corresponds to a RASS score of -1.

25. The method according to claim 23 or claim 24, wherein the desired anti-agitation effect is achieved without also producing clinically meaningful effects on blood pressure and/or heart rate.

26. The method according to any one of claims 23 to 25, wherein dexmedetomidine hydrochloride is administered intravenously as one or more discrete injections.

27. A method of treating agitation or signs of agitation in a human subject suffering from opioid withdrawal disorder who is alert prior to treatment, comprising administering dexmedetomidine hydrochloride intravenously to the subject at a total dose of about 3 meg to about 90 meg to achieve at least a 50% reduction in COW score.

28. The method according to claim 27, wherein the desired anti-agitation effect is achieved without also producing clinically meaningful effects on blood pressure and/or heart rate.

29. The method according to claims 27 to 28, wherein dexmedetomidine hydrochloride is administered intravenously as one or more discrete injections.

30. The method according to claims 27 to 28, wherein dexmedetomidine hydrochloride is administered intravenously as a continuous infusion.

31. The method according to claim 30, wherein the dose is about 0.3 mcg/kg/hr to 0.4 mcg/kg/hr.

32. A method of treating agitation or signs of agitation in a human subj ect suffering from senile dementia of the Alzheimer’s type (SDAT) who is alert prior to treatment, comprising administering to the subject dexmedetomidine hydrochloride intravenously by continuous infusion at an infusion rate up to about 0.5 mcg/kg/hr to achieve a maximum plasma concentration (Cmax) of up to about 400 pg/ml, together with the attainment of a mild sedative effect.

33. A method of treating agitation or signs of agitation in a human subject suffering from schizophrenia who is alert prior to treatment, comprising administering to the subject dexmedetomidine hydrochloride intravenously by continuous infusion at an infusion rate up to about 0.5 mcg/kg/hr to achieve a maximum plasma concentration (Cmax) of up to about 400 pg/ml,

wherein agitation is reduced to a value of 7 or below 7 according to the PEC scale, and wherein the reduction in agitation is associated with the attainment of a mild sedative effect.

34. A method of treating agitation or signs of agitation in a human subject suffering from opioid withdrawal disorder who is alert prior to treatment, comprising administering to the subject dexmedetomidine hydrochloride intravenously by continuous infusion at an infusion rate up to about 0.7 mcg/kg/hr to achieve a maximum plasma concentration (Cmax) of up to about 410 pg/ml, and at least a 50% reduction in COW score.