Methods of treating posttraumatic stress disorder with acamprosate salts
Inventors
Fogel, Barry S. • Kerns, William D. • Fong, Kei-Lai
Assignees
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Publication Number
US-10512621-B2
Publication Date
2019-12-24
Expiration Date
Abstract
Embodiments disclosed herein generally relate to methods of treating posttraumatic stress disorder (PTSD) using acamprosate formulations and/or acamprosate formulations in combination with at least one other medication, such as neuroleptic (antipsychotic) and/or antidepressant drugs.
Core Innovation
The patent describes treating posttraumatic stress disorder (PTSD) by administering acamprosate calcium, or other pharmaceutically acceptable salt of acamprosate, to a subject in need thereof. The improvement comprises administering a tablet that comprises acamprosate calcium, or the other pharmaceutically acceptable salt, distributed within a polymer matrix comprising or consisting of carbomer homopolymer type B.
The disclosed tablet formation provides gastroretentive and controlled-release behavior that alters acamprosate pharmacokinetics. Controlled release maintains drug concentration above a therapeutic threshold for only part of each 24-hour period, while supporting once- or twice-daily dosing and total daily doses under 1 gram.
The specification further describes an approximately linear rate of release with the square root of time and comparability across a pH range spanning at least pH 1.0 to pH 4.5. The patent also supports treating PTSD with co-therapy by administering an SSRI or SNRI, alone or in fixed-dose combinations, together with acamprosate calcium in the disclosed gastroretentive controlled-release formulation.
Claims Coverage
The document provides one independent claim directed to a specific gastroretentive controlled-release tablet formulation for treating PTSD, with dependent claims refining the tablet characteristics, the in vitro release profile, and optional combination therapy with an SSRI or SNRI. Across the claim set, the inventive features focus on formulation composition, the release profile constraints, and the option of SSRI/SNRI co-administration with specified agent options.
Ptdsd treatment with acamprosate calcium in a carbomer homopolymer type B polymer matrix
A method of treating posttraumatic stress disorder (PTSD) by administering acamprosate calcium, or other pharmaceutically acceptable salt of acamprosate, using a tablet that comprises acamprosate calcium, or the other pharmaceutically acceptable salt, distributed within a polymer matrix comprising or consisting of carbomer homopolymer type B.
Square-root-of-time release and pH comparability for the acamprosate tablet
The tablet releases acamprosate calcium, or other pharmaceutically acceptable salt of acamprosate, at an approximately linear rate with the square root of time, and the release remains comparable over a pH range spanning at least pH 1.0 to pH 4.5.
Ssri/snri co-therapy with the acamprosate tablet
The tablet further comprises a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI).
Selection of a specified SSRI/SNRI agent list for combination therapy
The SSRI or SNRI is selected from citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, fluvoxamine, milnacipran, paroxetine, sertraline, and venlafaxine.
Overall claim coverage centers on treating PTSD using an acamprosate calcium formulation distributed in a polymer matrix comprising or consisting of carbomer homopolymer type B, with dependent limitations specifying an approximately linear square-root-of-time in vitro release behavior and maintained comparability across a defined pH span. Additional dependent features add SSRI/SNRI co-therapy, including selection from a specified set of SSRI/SNRI agents.
Stated Advantages
Reduced GI side effects compared with enteric-coated acamprosate.
Improved convenience and compliance through once- or twice-daily dosing.
Lower Cmax.
Unexpected efficacy at a reduced daily dose, not necessarily reflected by equal or larger AUC.
Documented Applications
Treating posttraumatic stress disorder (PTSD) in a subject in need thereof using an acamprosate calcium, or pharmaceutically acceptable salt, gastroretentive/controlled-release tablet formulation.
Combination therapy use case where the subject receives or has received therapy with an SSRI or SNRI and receives acamprosate calcium, or pharmaceutically acceptable salt, together with the SSRI or SNRI.
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