Treatment of gastroparesis and nonulcer dyspepsia with GABAB agonists
OwnerJohn Devane, Jackie Butlerinventors
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Abstract
The present invention relates to formulations comprising a therapeutically effective amount of baclofen or (R)-baclofen, or pharmaceutically acceptable salts thereof, and methods of their use. The present formulations and methods are designed to release a therapeutic amount of baclofen in a manner that maximizes its therapeutic effect. The methods and formulations are especially suitable for treating gastroparesis and nonulcer dyspepsia.
Claims42
A method of treating gastroparesis in a subject in need of such treatment, comprising administering to said subject an effective amount of baclofen, or a pharmaceutically acceptable salt thereof, wherein at least one symptom of gastroparesis other than vomiting is relieved.
A method of treating nonulcer dyspepsia in a subject in need of such treatment, comprising administering to said subject an effective amount of baclofen, or a pharmaceutically acceptable salt thereof, wherein at least one symptom of nonulcer dyspepsia other than vomiting is relieved.
A pharmaceutically acceptable formulation comprising enriched (R)-baclofen, substantially pure (R)-baclofen, or a pharmaceutically acceptable salt thereof, in the form of a pharmaceutical dosage form for oral, intra-nasal, buccal, transdermal, parenteral, or sublingual administration.
A method of treating gastroparesis comprising administering a therapeutically effective amount of enriched (R)-baclofen, substantially pure (R)-baclofen, or a pharmaceutically acceptable salt thereof, to a subject in need of such a treatment, wherein the subject obtains a therapeutic benefit resulting from the administration of enriched (R)-baclofen or substantially pure (R)-baclofen, and wherein the amount of enriched (R)-baclofen, substantially pure (R)-baclofen, or pharmaceutically acceptable salt thereof, is less than the amount of racemic baclofen required to achieve the same therapeutic benefit.
A method of treating nonulcer dyspepsia comprising administering a therapeutically effective amount of enriched (R)-baclofen, substantially pure (R)-baclofen, or a pharmaceutically acceptable salt thereof, to a subject in need of such a treatment, wherein the subject obtains a therapeutic benefit resulting from the administration of enriched (R)-baclofen or substantially pure (R)-baclofen, and wherein the amount of enriched (R)-baclofen, substantially pure (R)-baclofen, or pharmaceutically acceptable salt thereof, is less than the amount of racemic baclofen required to achieve the same therapeutic benefit.
A method of reducing one or more side effects associated with racemic baclofen comprising administering a therapeutically effective amount of enriched (R)-baclofen, substantially pure (R)-baclofen, or a pharmaceutically acceptable salt thereof, to a subject in need of such a reduction, wherein one or more side-effects are reduced relative to those resulting from the administration of an equivalent amount of racemic baclofen.
A method of reducing one or more drug interactions associated with administration of racemic baclofen comprising administering a therapeutically effective amount of enriched (R)-baclofen, substantially pure (R)-baclofen, or a pharmaceutically acceptable salt thereof, to a subject in need of such a reduction, wherein one or more drug interactions are reduced relative to those resulting from the administration of an equivalent amount of racemic baclofen.
A method of extending the therapeutic effect of a treatment for gastroparesis comprising administering a therapeutically effective amount of enriched (R)-baclofen, substantially pure (R)-baclofen, or a pharmaceutically acceptable salt thereof, to a subject in need of such treatment, wherein the administration of enriched (R)-baclofen, substantially pure (R)-baclofen, or pharmaceutically acceptable salt thereof, provides a therapeutic effect that lasts longer than the therapeutic effect achieved by administration of an equal amount of racemic baclofen.
A method of extending the therapeutic effect of a treatment for nonulcer dyspepsia comprising administering a therapeutically effective amount of enriched (R)-baclofen, substantially pure (R)-baclofen, or a pharmaceutically acceptable salt thereof, to a subject in need of such treatment, wherein the administration of enriched (R)-baclofen, substantially pure (R)-baclofen, or pharmaceutically acceptable salt thereof, provides a therapeutic effect that lasts longer than the therapeutic effect achieved by administration of an equal amount of racemic baclofen.
Dependencies are inferred from the claim text.