Delivery Of Esketamine For The Treatment Of Depression

a technology of esketamine and depression, applied in the field of pharmaceutical products, can solve the problems of high relapse rate, significant morbidity and mortality of mdd, and disability worldwid

Inactive Publication Date: 2020-01-09
JANSSEN PHARMA NV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0008]The present invention is directed to methods for the treatment of depression (e.g., major depressive disorder), compri

Problems solved by technology

MDD is associated with significant morbidity and mortality and the leading cause of disability worldwide.
Such patients who do benefit with oral ADs have high rates of relapse even with continuation of treatment.
The impact of TRD on patient's lives is difficult to adequately describe.
In extreme cases they cannot even engage in basic self-care activities such as bathing

Method used

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  • Delivery Of Esketamine For The Treatment Of Depression
  • Delivery Of Esketamine For The Treatment Of Depression
  • Delivery Of Esketamine For The Treatment Of Depression

Examples

Experimental program
Comparison scheme
Effect test

example 1

Efficacy of Intranasal Esketamine for Treating Treatment Resistance Depression (TRD), Phase 3 Clinical Trial

[0501]The ability of esketamine to treat treatment-refractory or treatment-resistant depression (TRD) was evaluated via the clinical study described below, which was conducted to evaluate the efficacy, safety, and tolerability of flexibly dosed intranasal esketamine plus a newly initiated oral antidepressant in adult subjects with TRD. The study served as a pivotal Phase 3 short-term efficacy and safety study in support of regulatory agency requirements for registration of intranasal esketamine for the treatment of TRD.

[0502]The hypothesis for this study was that, in adult subjects with TRD, switching from a failed antidepressant treatment to intranasal esketamine plus a newly initiated oral antidepressant would be superior to switching to a newly initiated oral antidepressant treatment (active comparator) plus intranasal placebo in improving depressive symptoms.

[0503]The prim...

example 2

Efficacy of Intranasal Esketamine for Treating Treatment Resistance Depression (TRD) in Geriatric Patients, Phase 3 Clinical Trial

[0920]The ability of esketamine to treat treatment-refractory or treatment-resistant depression (TRD) was evaluated via the clinical study described below, which was conducted to evaluate the efficacy, safety, and tolerability of flexibly dosed intranasal esketamine plus a newly initiated oral antidepressant in elderly subjects with TRD. The study served as a pivotal Phase 3 short-term efficacy and safety study in support of regulatory agency requirements for registration of intranasal esketamine for the treatment of TRD. A diagram of the study design is provided in FIG. 18.

[0921]The hypothesis for this study was that, in elderly subjects with TRD, switching from a failed antidepressant treatment to intranasal esketamine plus a newly initiated oral antidepressant would be superior to switching to a newly initiated oral antidepressant treatment (active com...

example 3

[1003]This was a randomized, double-blind, placebo-controlled, multicenter study. See, Canuso, “Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized Placebo-Controlled Study,” Am. J. Psych., 2018, 1-11, which is herein incorporated by reference. Approximately 70 male and female subjects, 19 to 64 years of age, with MDD at imminent risk for suicide presenting to an emergency room (ER) or other permitted setting and assessed to be at imminent risk for suicide were enrolled. The majority of subjects were female, and the mean age of all subjects was approximately 36 years. The mean baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score was over 38 (corresponding to severe depression), and the mean baseline Beck Scale for Suicidal Ideation (BSS) score was over 22. Over half of the subjects had a score of 6 on the Suicide Ideation and Be...

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Abstract

The present invention provides devices and methods for treating depression in a patient, comprising administering to the patient in need of the treatment a therapeutically effective amount of esketamine. In some embodiments, the depression is major depressive disorder or treatment resistant depression. In other embodiments, the therapeutically effective amount is clinically proven safe and/or effective. Also provided are methods to mitigate the risk or misuse or abuse of esketamine, instructions for use of the esketamine product, and methods for selling a drug product containing esketamine.

Description

RELATED APPLICATION DATA[0001]This patent application claims priority of application Ser. No. 29 / 617,294, filed on Sep. 13, 2017, Application No. 62 / 813,767, filed on Mar. 5, 2019, and Application No. 62 / 814,274, filed on Mar. 5, 2019, the entire contents of each being incorporated herein by reference.FIELD OF THE INVENTION[0002]The present invention is directed to pharmaceutical products, and to methods for the treatment of depression (e.g., major depressive disorder). In some embodiments, the methods are useful for the treatment of treatment-refractory or treatment-resistant depression. In other embodiments, the methods are useful for the treatment of suicidal ideation. The invention comprises administering to a patient in need thereof a clinically proven safe and therapeutically effective amount of esketamine as mono-therapy or as combination therapy with at least one antidepressant.BACKGROUND OF THE INVENTION[0003]Major depressive disorder (MDD) affects about 7-15% of the genera...

Claims

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Application Information

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IPC IPC(8): A61K31/135A61M5/315A61K9/00
CPCA61K9/008A61K9/0043A61K31/135A61M5/31533A61M15/08A61M2205/583A61M2209/06A61M11/007
Inventor WANG, JINGLICANNAMELA, MICHAELYAN, HONGKLEINBERG, ROCHELLE
Owner JANSSEN PHARMA NV
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