US 12,186,296 B1
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Claire Megret, Lyons (FR); Herve Guillard, Villeurbanne (FR); and Jean-Francois Dubuisson, Lyons (FR)
Assigned to Flamel Ireland Limited, Dublin (IE)
Filed by Flamel Ireland Limited, Dublin (IE)
Filed on Feb. 17, 2021, as Appl. No. 17/178,117.
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.
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.
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)] 63 Claims
 
1. A method of treating a disorder treatable with gamma-hydroxybutyrate in a human patient in need thereof, the method comprising:
orally administering a dosage of a composition comprising gamma-hydroxybutyrate only once per night,
wherein the composition comprises an immediate-release portion and a modified-release portion, and
wherein the patient experiences fewer adverse reactions as compared to administration of a comparable amount of a twice-nightly, immediate release liquid solution of sodium oxybate divided into two separate doses, wherein a first dose of the liquid solution is administered 2.5-4 hours prior to administration of a second dose of the liquid solution each night.