Last Updated: May 10, 2026

Claims for Patent: 11,583,510

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Summary for Patent: 11,583,510

Title:	Methods of administering gamma hydroxybutyrate formulations after a high-fat meal
Abstract:	Provided herein are methods of administering a once-nightly dosage of gamma-hydroxybutyrate after a high-fat meal.
Inventor(s):	Julien Grassot, David Monteith, Hervé Guillard, Claire Mégret, Jean-François DUBUISSON
Assignee:	Flamel Ireland Ltd
Application Number:	US17/666,205
Patent Claims:	1. A method of treating narcolepsy, cataplexy, or excessive daytime sleepiness in a human subject in need thereof, the method comprising orally administering to the subject a once-nightly dosage of a gamma-hydroxybutyrate formulation comprising an immediate release portion and a modified release portion, wherein oral administration immediately after a high-fat meal results in a mean reduction in Cmax of gamma-hydroxybutyrate by 33% and a Tmax of gamma-hydroxybutyrate that is approximately 1 h longer as compared to administering the once-nightly dosage in a fasted state. 2. The method of claim 1, wherein mean Cmax in a fed state is 64.0 μg/mL. 3. The method of claim 1, wherein fat comprises 50% of the total content of the high-fat meal. 4. The method of claim 1, wherein the high-fat meal comprises 500-600 kcal derived from fat. 5. The method of claim 1, wherein AUCinf is lower in a fed state as compared to a fasted state. 6. The method of claim 1, further comprising advising the human subject that consumption of alcohol is contraindicated with the once nightly dosage and may result in a more rapid release of the gamma-hydroxybutyrate. 7. The method of claim 1, wherein the modified release portion comprises microparticles comprising gamma-hydroxybutyrate. 8. The method of claim 1, wherein the immediate release portion comprises microparticles comprising gamma-hydroxybutyrate. 9. A method of treating narcolepsy, cataplexy, or excessive daytime sleepiness in a human subject in need thereof, the method comprising orally administering a gamma-hydroxybutyrate formulation to the subject, wherein the administering occurs only once daily, and wherein oral administration of the formulation immediately after a high-fat meal results in a mean reduction in Cmax of gamma-hydroxybutyrate by 33% and an average Tmax increase of gamma-hydroxybutyrate from 0.5 hr to 1.5 hr as compared to administering the formulation in a fasted state. 10. The method of claim 9, wherein mean Cmax of gamma-hydroxybutyrate in a fed state is 64.0 μg/mL. 11. The method of claim 9, wherein fat comprises 50% of the total content of the high-fat meal. 12. The method of claim 9, wherein the high-fat meal comprises 500-600 kcal derived from fat. 13. The method of claim 9, wherein AUCinf is lower in a fed state as compared to a fasted state. 14. The method of claim 9, further comprising advising the human subject that consumption of alcohol is contraindicated with the formulation and may result in a more rapid release of gamma-hydroxybutyrate.

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