Methods and compositions for treatment of epileptic disorders
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Publication Number
US-11806336-B2
Publication Date
2023-11-07
Expiration Date
Abstract
Use of allosteric modulators and/or gaboxadol for the treatment of epileptic disorders in a subject in need thereof.
Core Innovation
The disclosed invention relates to methods of treating epileptic disorders, including Lennox-Gastaut syndrome, by administering pharmaceutical compositions that comprise ganaxolone or a pharmaceutically acceptable salt thereof. In at least one disclosed method, the pharmaceutical composition is administered as an oral suspension. The disclosure frames the treatment around allosteric modulators and neurosteroids as part of epileptic-disorder therapy.
The invention further addresses treatment of epileptic disorders by providing dosing and exposure constraints for ganaxolone-based therapy, including in vivo plasma profile targets. In particular, the disclosure includes pharmacokinetic exposure thresholds such as a Cmax less than about 500 ng/mL and an AUC0-∞ less than about 900 ng·hr/mL. Clinical effect duration targets are also disclosed, including symptom improvement lasting more than specified hour thresholds.
The disclosed content also includes broader therapeutic context for epileptic disorders using allosteric modulators and/or gaboxadol (THIP), including combination therapy. Additionally, the disclosure contains parenteral gaboxadol formulations with stability and solubility considerations and provides preclinical and early clinical-style pharmacokinetic and pharmacodynamic rationale, including gaboxadol PK/residual-effect testing and rat studies evaluating gaboxadol and related neurosteroids in benzodiazepine-resistant status epilepticus.
Claims Coverage
The independent claims cover administering a ganaxolone-containing pharmaceutical composition to treat Lennox-Gastaut syndrome, with claim families adding pharmacokinetic constraints and clinical symptom-improvement duration constraints. Across the two independent claims, the main inventive features are grounded in the target condition, the active agent, the administration format, and constrained in vivo plasma exposure and symptom improvement duration in dependents.
Treatment of Lennox-Gastaut syndrome with ganaxolone oral suspension
Administering to a patient in need thereof a pharmaceutical composition comprising ganaxolone or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition is administered as an oral suspension.
Treatment of Lennox-Gastaut syndrome in a diagnosed human patient
Administering to a human patient diagnosed with Lennox-Gastaut syndrome a pharmaceutical composition comprising ganaxolone or a pharmaceutically acceptable salt thereof.
Pharmacokinetic exposure constraint with a Cmax threshold
A method wherein the pharmaceutical composition provides an in vivo plasma profile with a Cmax of less than about 500 ng/ml.
Pharmacokinetic exposure constraint with an AUC threshold
A method wherein the pharmaceutical composition provides an in vivo plasma profile with an AUC of less than about 900 ng·hr/ml.
Symptom improvement lasting beyond a post-administration threshold
The method provides a patient with improvement of at least one symptom lasting more than 4 hours after administering a pharmaceutical composition.
Overall claim coverage centers on treating Lennox-Gastaut syndrome using ganaxolone or a pharmaceutically acceptable salt with oral suspension administration in at least one claim, and dependent-claim limitations that constrain in vivo plasma exposure and require symptom improvement duration beyond specified hour thresholds.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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