Esketamine for the treatment of depression
AssigneeJanssen Pharmaceutica NV
InventorsJaskaran Singh, Ella Daly, Margaret Fedgchin, David Hough, Vanina Popova
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Abstract
The present invention provides 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.
Claims33
A method of treating major depressive disorder in a human patient in need thereof based on a dosing regimen, said regimen having an induction phase and, a subsequent maintenance phase, wherein the induction phase has a duration of 4 weeks, the method comprising:
- intranasally administering an aqueous formulation comprising esketamine and/or a pharmaceutically acceptable salt thereof in the induction phase to provide a therapeutically effective amount of about 56 mg or about 84 mg of esketamine per induction phase treatment session to the patient, wherein the induction phase treatment session occurs at a frequency of twice weekly during the induction phase;
- and
- intranasally administering an aqueous formulation comprising esketamine and/or a pharmaceutically acceptable salt thereof in the maintenance phase to provide a therapeutically effective amount of about 56 mg or about 84 mg of esketamine per maintenance phase treatment session to the patient, wherein the maintenance phase treatment session occurs at a frequency of once weekly or once every other week during the maintenance phase;
- and
- wherein the patient has a worsening of depression symptoms following a missed treatment session during the maintenance phase and is returned to a previously higher frequency of treatment session before the missed treatment session.
Dependencies are inferred from the claim text.