US 12,226,388 B2
Modified release gamma- hydroxybutyrate formulations having improved pharmacokinetics
Claire Mégret, Lyons (FR); Hervé Guillard, Villeurbanne (FR); and Jean-François Dubuisson, Lyons (FR)
Assigned to Flamel Ireland Limited, Dublin (IE)
Filed by Flamel Ireland Limited, Dublin (IE)
Filed on Jun. 28, 2024, as Appl. No. 18/758,699.
Application 18/758,699 is a continuation of application No. 18/643,773, filed on Apr. 23, 2024.
Application 18/643,773 is a continuation of application No. 17/530,096, filed on Nov. 18, 2021, granted, now 11,986,451, issued on May 21, 2024.
Application 17/530,096 is a continuation in part of application No. 17/178,117, filed on Feb. 17, 2021.
Application 17/178,117 is a continuation in part of application No. 16/527,633, filed on Jul. 31, 2019, granted, now 11,065,224, issued on Jul. 20, 2021.
Application 16/527,633 is a continuation of application No. 16/281,235, filed on Feb. 21, 2019, granted, now 10,736,866, issued on Aug. 11, 2020.
Application 16/281,235 is a continuation of application No. 15/655,924, filed on Jul. 21, 2017, granted, now 10,272,062, issued on Apr. 30, 2019.
Claims priority of provisional application 62/474,330, filed on Mar. 21, 2017.
Claims priority of provisional application 62/399,413, filed on Sep. 25, 2016.
Claims priority of provisional application 62/365,812, filed on Jul. 22, 2016.
Prior Publication US 2024/0374549 A1, Nov. 14, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/22 (2006.01); A61K 9/14 (2006.01); A61K 9/16 (2006.01); A61K 9/50 (2006.01); A61K 31/19 (2006.01)
CPC A61K 31/22 (2013.01) [A61K 9/14 (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 31/19 (2013.01)] 29 Claims
 
1. A method of treating a disorder treatable with a pharmaceutically acceptable salt of gamma-hydroxybutyrate in a human subject in need thereof, the method comprising:
orally administering a single nighttime daily dose to said human,
wherein said single nighttime daily dose comprises a first salt of gamma-hydroxybutyric acid and a second salt of gamma-hydroxybutyric acid,
wherein the first salt is selected from the group consisting of a sodium salt of gamma-hydroxybutyric acid, a calcium salt of gamma-hydroxybutyric acid, a potassium salt of gamma-hydroxybutyric acid, and a magnesium salt of gamma-hydroxybutyric acid,
wherein the second salt differs from the first salt and is selected from the group consisting of a sodium salt of gamma-hydroxybutyric acid, a calcium salt of gamma-hydroxybutyric acid, a potassium salt of gamma-hydroxybutyric acid, and a magnesium salt of gamma-hydroxybutyric acid, and
wherein the orally administering occurs only once nightly; and
uptitrating the single nighttime daily dose in increments equivalent to about 1.5 g of sodium oxybate per night at weekly intervals to effect.