US 12,263,151 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 Sep. 18, 2024, as Appl. No. 18/889,055.
Application 18/889,055 is a continuation of application No. 18/759,320, filed on Jun. 28, 2024.
Application 18/759,320 is a continuation of application No. 18/643,773, filed on Apr. 23, 2024, granted, now 12,128,021.
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, granted, now 12,186,296.
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 2025/0009705 A1, Jan. 9, 2025
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)] 15 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 formulation that comprises an immediate-release portion and a modified-release portion to the patient, wherein
the orally administering occurs only once daily at bedtime,
the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 4.5 g, 6.0 g, or 7.5 g of sodium oxybate,
after the orally administering, the formulation releases gamma-hydroxybutyrate into the blood stream of the patient, and
the formulation achieves a mean C8h of:
from 4.7 to 9.0 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 4.5 g of sodium oxybate,
from 6.3 to 16.7 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 6.0 g of sodium oxybate, or
from 13.0 to 40.3 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 7.5 g of sodium oxybate.