US 11,986,451 B1
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 Nov. 18, 2021, as Appl. No. 17/530,096.
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.
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)] 26 Claims
 
1. A method of treating narcolepsy-related cataplexy or excessive daytime sleepiness in a human patient in need thereof, the method comprising:
initiating a dosage of a gamma-hydroxybutyrate (GHB) formulation equivalent to 4.5 g of sodium oxybate once per night orally, wherein the GHB formulation comprises an immediate-release (IR) portion and a modified-release (MR) portion, and wherein the GHB of the IR portion is the same as or different from the GHB of the MR portion;
up-titrating the once per night dosage in an amount equivalent to 1.5 g of sodium oxybate,
maintaining the up-titrated once per night dosage for at least a week before any further up-titrating; and
ceasing any further up-titrating upon effect.