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Last Updated: March 17, 2025

Claims for Patent: 11,826,335

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Summary for Patent: 11,826,335

Title:	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Abstract:	Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.
Inventor(s):	Jordan Dubow, Hervé Guillard, Claire Mégret, Jean-François DUBUISSON
Assignee:	Flamel Ireland Ltd
Application Number:	US18/096,508
Patent Claims:	1. A method of treating cataplexy or excessive daytime sleepiness in a human subject with narcolepsy, the method comprising: administering to the human subject a single dose of a formulation comprising gamma-hydroxybutyrate (GHB) in an amount equivalent to 6 g of sodium oxybate, wherein a ratio of GHB in an immediate-release portion of the formulation and a modified-release portion of the formulation is from 10/90 to 65/35, and wherein the administering results in a peak plasma concentration (Cmax) of about 66 mcg/mL. 2. The method of claim 1, wherein the time to peak plasma concentration (Tmax) following the administering is about 1.5 hours. 3. The method of claim 1, wherein the GHB of the formulation comprises a salt of GHB. 4. The method of claim 1, wherein the GHB of the formulation comprises sodium oxybate. 5. The method of claim 1, wherein the GHB of the formulation is sodium oxybate. 6. A method of treating cataplexy or excessive daytime sleepiness in a human subject with narcolepsy, the method comprising: administering to the human subject a single dose of a formulation comprising GHB in an amount equivalent to 5 g of oxybate, wherein a ratio of GHB in an immediate-release portion of the formulation and a modified-release portion of the formulation is from 10/90 to 65/35; and producing a peak plasma concentration (Cmax) of about 66 mcg/mL as a result of the administering. 7. The method of claim 6, wherein the time to peak plasma concentration (Tmax) following the administering is about 1.5 hours. 8. The method of claim 6, wherein the GHB of the formulation comprises a salt of GHB. 9. The method of claim 6, wherein the GHB of the formulation comprises sodium oxybate. 10. The method of claim 6, wherein the GHB of the formulation is sodium oxybate.

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