IP Library › Patent Application 18804196
Patent Application
App. No. 18/804,196

THERAPEUTIC METHODS USING BUPROPION HYDROBROMIDE

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Patent No.
US None
App. No.
18/804,196
Abstract

Disclosed are methods of treating a patient having Major Depressive Disorder (MDD) or Treatment Resistant Depression (TRD). The methods include administering to the patient a therapeutically effective amount of bupropion hydrobromide in extended-release form. The methods are more therapeutically effective in treating MDD or TRD than administration of an equivalent plasma dose of bupropion hydrochloride in extended-release form. In addition or alternatively, the therapeutically effective amount of bupropion hydrobromide reduces the incidence of one or more adverse events (anxiety, agitation and/or insomnia), when compared to the administration of the equivalent plasma dose of bupropion hydrochloride in extended-release form.

Claims (26)

1 . A method of treating a patient having Treatment Resistant Depression (TRD), the method comprising:

selecting a TRD patient who previously tried bupropion hydrochloride in extended-release form at an adequate plasma dose for an adequate duration in a current depressive episode and experienced an inadequate therapeutic response; and

administering to the patient a therapeutically effective amount of bupropion hydrobromide in extended-release form, wherein the bupropion hydrobromide in extended-release form is more therapeutically effective in treating TRD in the patient than administration of an equivalent plasma dose of bupropion hydrochloride in extended-release form.

2 . The method of claim 1 , wherein the therapeutically effective amount of bupropion hydrobromide in extended-release form is 174 mg of bupropion hydrobromide and the equivalent plasma dose of bupropion hydrochloride in extended-release form is 150 mg of bupropion hydrochloride.

3 . The method of claim 1 , wherein the therapeutically effective amount of bupropion hydrobromide in extended-release form is 348 mg of bupropion hydrobromide and the equivalent plasma dose of bupropion hydrochloride in extended-release form is 300 mg of bupropion hydrochloride.

4 . The method of claim 1 , wherein the therapeutically effective amount of bupropion hydrobromide in extended-release form is 522 mg of bupropion hydrobromide and the equivalent plasma dose of bupropion hydrochloride in extended-release form is 450 mg of bupropion hydrochloride.

5 . The method of claim 1 , wherein the therapeutically effective amount of bupropion hydrobromide in extended-release form is from 150 mg to 800 mg of bupropion hydrobromide and the equivalent plasma dose of bupropion hydrochloride in extended-release form is from 84 to 88% of the dose of the therapeutically effective amount of bupropion hydrobromide.

6 . The method of claim 5 , wherein the equivalent plasma dose of bupropion hydrochloride in extended-release form is about 86.2% of the dose of the therapeutically effective amount of bupropion hydrobromide.

7 . The method of claim 1 , wherein the method is adjunctive to administration of a second drug to treat the patient.

8 . The method of claim 1 , wherein the patient previously tried and failed at least one selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) that had been administered for adequate dose and duration or that had been discontinued due to side effects.

9 . The method of claim 1 , wherein the patient who previously tried bupropion hydrochloride in extended-release form experienced one or more side effects selected from the group consisting of anxiety, agitation and insomnia and wherein the one or more side effects were reduced or ameliorated when the patient was administered the therapeutically effective amount of bupropion hydrobromide in extended-release form.

10 . A method of treating a patient having Treatment Resistant Depression (TRD), the method comprising:

selecting a TRD patient who previously tried bupropion hydrochloride in extended-release form at a therapeutic plasma dose, but had to discontinue the bupropion hydrochloride in extended-release form due to side effects; and

administering to the patient a therapeutically effective amount of bupropion hydrobromide in extended-release form, wherein the effective amount of bupropion hydrobromide in extended-release form reduces or ameliorates one or more side effects selected from the group consisting of anxiety, agitation and insomnia, compared to administration of an equivalent plasma dose of bupropion hydrochloride in extended-release form.

11 . The method of claim 10 , wherein the therapeutically effective amount of bupropion hydrobromide in extended-release form is 174 mg of bupropion hydrobromide and the equivalent plasma dose of bupropion hydrochloride in extended-release form is 150 mg of bupropion hydrochloride.

12 . The method of claim 10 , wherein the therapeutically effective amount of bupropion hydrobromide in extended-release form is 348 mg of bupropion hydrobromide and the equivalent plasma dose of bupropion hydrochloride in extended-release form is 300 mg of bupropion hydrochloride.

13 . The method of claim 10 , wherein the therapeutically effective amount of bupropion hydrobromide in extended-release form is 522 mg of bupropion hydrobromide and the equivalent plasma dose of bupropion hydrochloride in extended-release form is 450 mg of bupropion hydrochloride.

14 . The method of claim 10 , wherein the therapeutically effective amount of bupropion hydrobromide in extended-release form is from 150 mg to 800 mg of bupropion hydrobromide and the equivalent plasma dose of bupropion hydrochloride in extended-release form is from 84 to 88% of the dose of the therapeutically effective amount of bupropion hydrobromide.

15 . The method of claim 14 , wherein the equivalent plasma dose of bupropion hydrochloride in extended-release form is about 86.2% of the dose of the therapeutically effective amount of bupropion hydrobromide.

16 . The method of claim 10 , wherein the method is adjunctive to administration of a second drug to treat the patient.

17 . The method of claim 10 , wherein the patient previously tried and failed at least one selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) that had been administered for adequate dose and duration or that had been discontinued due to side effects.

18 . A method of treating a patient having Treatment Resistant Depression (TRD), the method comprising:

selecting a TRD patient that previously tried bupropion hydrochloride in extended-release form at an adequate plasma dose for an adequate duration in a current depressive episode and experienced an inadequate therapeutic response and side effects; and

administering to the patient a therapeutically effective amount of bupropion hydrobromide in extended-release form, wherein the bupropion hydrobromide in extended-release form is more therapeutically effective in treating TRD than administration of an equivalent plasma dose of bupropion hydrochloride in extended-release form, and wherein the therapeutically effective amount of bupropion hydrobromide reduces or ameliorates one or more side effects selected from the group consisting of anxiety, agitation and insomnia, when compared to administration of the equivalent plasma dose of bupropion hydrochloride in extended-release form.

19 . The method of claim 18 , wherein the therapeutically effective amount of bupropion hydrobromide in extended-release form is from 150 mg to 800 mg of bupropion hydrobromide and the equivalent plasma dose of bupropion hydrochloride in extended-release form is from 84 to 88% of the dose of the therapeutically effective amount of bupropion hydrobromide.

20 . The method of claim 18 , wherein the method is adjunctive to administration of a second drug to treat the patient.