	US 12,303,478 B2
	Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
Julien Grassot, Lyons (FR); Cendrine Grangeon, Villeurbanne (FR); and Jordan Dubow, Chicago, IL (US)
Assigned to Flamel Ireland Limited, Dublin (IE)
Filed by Flamel Ireland Limited, Dublin (IE)
Filed on Sep. 26, 2024, as Appl. No. 18/898,132.
Application 18/898,132 is a continuation of application No. 18/758,344, filed on Jun. 28, 2024, granted, now 12,167,991.
Application 18/758,344 is a continuation of application No. 17/837,740, filed on Jun. 10, 2022.
Application 17/837,740 is a continuation of application No. 16/804,966, filed on Feb. 28, 2020, granted, now 11,400,065.
Claims priority of provisional application 62/812,699, filed on Mar. 1, 2019.
Claims priority of provisional application 62/857,008, filed on Jun. 4, 2019.
Prior Publication US 2025/0017882 A1, Jan. 16, 2025
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/19 (2006.01); A61K 9/00 (2006.01)

CPC A61K 31/19 (2013.01) [A61K 9/0053 (2013.01); A61K 9/009 (2013.01); A61K 9/0095 (2013.01)]

30 Claims

1. A method of decreasing excessive daytime sleepiness in a human patient, the method comprising:

orally administering a formulation that comprises an immediate-release portion and a modified-release portion to the patient, wherein the formulation comprises an amount of gamma-hydroxybutyrate equivalent to from 3.0 g to 12 g of sodium oxybate,

wherein the orally administering occurs only once daily at bedtime,

wherein, the administered formulation releases gamma-hydroxybutyrate info the blood stream of the patient, and

wherein the C_maxof the formulation is dose proportional.