	US 12,295,926 B1
	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Julien Grassot, Lyons (FR); David Monteith, Lyons (FR); Hervé Guillard, Villeurbanne (FR); Claire Mégret, Lyons (FR); and Jean-François Dubuisson, Lyons (FR)
Assigned to Flamel Ireland Limited, Dublin (IE)
Filed by Flamel Ireland Limited, Dublin (IE)
Filed on Apr. 28, 2022, as Appl. No. 17/731,562.
Application 17/731,562 is a division of application No. 17/666,205, filed on Feb. 7, 2022, granted, now 11,583,510.
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/19 (2006.01); A61K 9/16 (2006.01); A61K 9/50 (2006.01); A61K 31/22 (2006.01); A61P 25/20 (2006.01)

CPC A61K 31/19 (2013.01) [A61K 9/1676 (2013.01); A61K 9/5015 (2013.01); A61K 9/5026 (2013.01); A61K 9/5042 (2013.01); A61K 9/5078 (2013.01); A61K 9/5084 (2013.01); A61K 31/22 (2013.01); A61P 25/20 (2018.01)]

7 Claims

1. A method of treating a disorder treatable with gamma-hydroxybutyrate in a human subject in need thereof, the method comprising orally administering to the subject a particulate pharmaceutical composition that releases gamma-hydroxybutyrate into the blood stream, wherein the orally administering occurs only once nightly, and wherein oral administration immediately after a high-fat meal results in a mean reduction in AUC of gamma-hydroxybutyrate by 14% and a T_maxof gamma-hydroxybutyrate that is approximately 1 h longer as compared to administering the particulate pharmaceutical composition in a fasted state.