US 12,167,992 B2
Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
Julien Grassot, Lyons (FR); Cendrine Grangeon, Villeurbanne (FR); and Jordan Dubow, Lyons (FR)
Assigned to Flamel Ireland Limited, Dublin (IE)
Filed by Flamel Ireland Limited, Dublin (IE)
Filed on Jun. 28, 2024, as Appl. No. 18/758,358.
Application 18/758,358 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 62/857,008, filed on Jun. 4, 2019.
Claims priority of provisional application 62/812,699, filed on Mar. 1, 2019.
Prior Publication US 2024/0350438 A1, Oct. 24, 2024
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)] 26 Claims
 
1. A method of decreasing excessive daytime sleepiness in a human subject in need thereof, the method comprising:
orally administering a pharmaceutical composition comprising first and second salts of gamma-hydroxybutyrate to said human subject, wherein
said first salt is selected from the group consisting of sodium oxybate, calcium oxybate, magnesium oxybate, and potassium oxybate,
said second salt differs from said first salt and is selected from the group consisting of sodium oxybate, calcium oxybate, magnesium oxybate, and potassium oxybate, and
wherein the orally administering occurs only once daily, and most adverse events (AEs) occur 1.5-2 hours after dosing.