US 12,186,298 B2
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Jordan Dubow, 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 Jun. 28, 2024, as Appl. No. 18/758,081.
Application 18/758,081 is a continuation of application No. 18/537,342, filed on Dec. 12, 2023.
Application 18/537,342 is a continuation of application No. 18/231,581, filed on Aug. 8, 2023, granted, now 11,896,572.
Application 18/231,581 is a continuation of application No. 18/075,980, filed on Dec. 6, 2022, granted, now 11,766,418.
Application 18/075,980 is a continuation of application No. 17/497,393, filed on Oct. 8, 2021, granted, now 11,602,513, issued on Mar. 14, 2023.
Application 17/497,393 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 2024/0358666 A1, Oct. 31, 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)] 26 Claims
 
1. A method of treating a disorder treatable with gamma-hydroxybutyrate 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,
the pharmaceutical composition comprises an amount of salts of gamma-hydroxybutyric acid equivalent to 1.5 g, 3.0 g, 4.5 g, 6.0 g, 7.5 g, or 9.0 g of sodium oxybate,
the orally administering occurs only once daily at bedtime, and
the orally administering occurs at least 2 hours after eating.