Methods of treating depressive disorders
Inventors
HARDEN, Cynthia Louise • Beatch, Gregory N.
Assignees
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Publication Number
US-12178811-B2
Publication Date
2024-12-31
Expiration Date
Abstract
In certain embodiments, the present disclosure is directed to methods for treating depressive disorders in a human, wherein the methods comprise orally administering a therapeutically effective amount of N-[4-(6-fluoro-3,4-dihydro-1H-isoquinolin-2-yl)-2,6-dimethylphenyl]-3,3-dimethylbutanamide (Compound A), to the human in need thereof. The present disclosure is further directed to various improved methods of therapy and administration of Compound A.
Core Innovation
The disclosed invention relates to methods of treating a depressive disorder in a human in need thereof by administering a therapeutically effective amount of Compound A, identified as N-[4-(6-fluoro-3,4-dihydro-1H-isoquinolin-2-yl)-2,6-dimethylphenyl]-3,3-dimethylbutanamide. The method includes administering Compound A under fed conditions.
The disclosure frames the method for treating depressive disorders including major depressive disorder (MDD), disruptive mood dysregulation disorder, persistent depressive disorder, bipolar spectrum disorder, postpartum depression, premenstrual dysphoric disorder (PMDD), seasonal affective disorder (SAD), atypical depression, and treatment-resistant depression (TRD). It also includes depression associated with agitation or anxiety, adjustment disorder with depressed mood, prolonged depressive reaction, and combinations thereof.
The disclosure further characterizes the functional basis as enhancement and/or selective opening of Kv7 potassium channels, including Kv7.2 and Kv7.3. It also provides supporting evidence including in vivo efficacy in a mouse forced swim test, including latency to immobility and duration of immobility, and reports central nervous system exposure using a brain-to-plasma ratio.
Claims Coverage
The provided independent claim is clm-00001, which recites a method of treating a depressive disorder in a human by administering a therapeutically effective amount of Compound A under fed conditions. The related dependent claim set identifies key inventive refinements including depressive disorder scope, meal-timing administration, quantitative dosing ranges, and mechanistic action via Kv7 potassium channel opening enhancement.
Treating a depressive disorder in a human with Compound A
A method of treating a depressive disorder in a human in need thereof, comprising administering a therapeutically effective amount of Compound A to the human, wherein Compound A is N-[4-(6-fluoro-3,4-dihydro-1H-isoquinolin-2-yl)-2,6-dimethylphenyl]-3,3-dimethylbutanamide.
Oral administration under fed conditions
Compound A is orally administered to the human under fed conditions.
Fed-condition meal-timing administration window
Compound A is orally administered within a time window of about 30 minutes before to about 2 hours after eating a meal.
Enhancing opening of Kv7 potassium channels
Enhancing the opening of a Kv7 potassium channel in a human.
Enhancement and selective opening of Kv7.2 and Kv7.3 channels
Enhancing and/or selective opening of Kv7 potassium channels including Kv7.2 and Kv7.3.
Depressive disorder scope including specified disorder types
The method applies when the depressive disorder is one of several specified depressive disorder types or combinations thereof including major depressive disorder (MDD), disruptive mood dysregulation disorder, persistent depressive disorder, bipolar spectrum disorder, postpartum depression, premenstrual dysphoric disorder (PMDD), seasonal affective disorder (SAD), atypical depression, and treatment-resistant depression (TRD), and also includes additional listed depressive disorder forms or combinations thereof.
Overall, the claim coverage centers on treating a depressive disorder in a human using orally administered Compound A under fed conditions, with claim refinements covering meal-timing, specified depressive disorder categories, quantitative dosing constraints, and a Kv7 potassium channel mechanism characterized by enhanced and selective opening of Kv7 channels including Kv7.2 and Kv7.3.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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