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Last Updated: March 17, 2025

Claims for Patent: 11,779,557

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Summary for Patent: 11,779,557

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, Cendrine Grangeon, Hervé Guillard, Claire Mégret, Jean-François DUBUISSON
Assignee:	Flamel Ireland Ltd
Application Number:	US17/666,201
Patent Claims:	1. A method of treating cataplexy or excessive daytime sleepiness in a human patient with narcolepsy, the method comprising: determining the patient has an apnea/hypopnea index equal to or lower than 15; prescribing to the patient a once-nightly formulation that, after oral administration, releases gamma-hydroxybutyrate into the bloodstream of the patient, wherein the formulation includes an immediate-release portion and a modified-release portion, wherein each once-nightly dosage of the formulation releases an amount of gamma-hydroxybutyrate into the bloodstream equivalent to 3 g to 9 g of sodium oxybate, and wherein the prescribing takes place after the determining; and instructing the patient to take the formulation only once per night while in bed and to lie down immediately after dosing. 2. The method of claim 1, wherein oral administration to the patient does not provide a clinically significant worsening of respiratory function as measured by apnea/hypopnea index and pulse oximetry. 3. The method of claim 1, wherein oral administration to the patient provides fewer instances of central apnea as compared to immediate-release sodium oxybate. 4. The method of claim 1, wherein oral administration to the patient does not result in an oxygen desaturation of ≤55%. 5. The method of claim 1, further comprising measuring polysomnography (PSG) of the patient. 6. A method of treating cataplexy or excessive daytime sleepiness in a human subject with narcolepsy: identifying a first and a second human subject as having narcolepsy and being in need of treatment for cataplexy or excessive daytime sleepiness; determining that the first subject has an apnea/hypopnea index equal to or lower than 15 and that the second subject has an apnea/hypopnea index greater than 15; based, at least in part on the determining, prescribing to the first subject a once-nightly formulation that, after oral administration, releases gamma-hydroxybutyrate into the bloodstream of the patient, wherein the formulation includes an immediate-release portion and a modified-release portion, wherein each once-nightly dosage of the formulation releases an amount of gamma-hydroxybutyrate into the bloodstream equivalent to 4.5 g to 9 g of sodium oxybate; and excluding the second subject from treatment with the formulation based, at least in part, on the determining.

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