	US 11,944,597 B2
	Pharmacokinetics of combined release formulations of a gamma-hydroxybutyric acid derivative
Daniel M. Canafax, Half Moon Bay, CA (US); William W. Xiang, Fremont, CA (US); Leonard Blum, Edina, MN (US); and Jia-Ning Xiang, Fremont (UA)
Assigned to XWPHARMA LTD., Grand Cayman (KY)
Filed by XWPHARMA LTD., Grand Cayman (KY)
Filed on Oct. 26, 2022, as Appl. No. 17/974,316.
Application 17/974,316 is a continuation of application No. 17/698,609, filed on Mar. 18, 2022, granted, now 11,510,892.
Claims priority of provisional application 63/163,096, filed on Mar. 19, 2021.
Prior Publication US 2023/0067371 A1, Mar. 2, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/22 (2006.01); A61K 9/00 (2006.01); A61K 9/48 (2006.01); A61K 9/50 (2006.01)

CPC A61K 31/22 (2013.01) [A61K 9/0053 (2013.01); A61K 9/485 (2013.01); A61K 9/4866 (2013.01); A61K 9/5047 (2013.01)]

22 Claims

1. A method of treating narcolepsy, excessive daytime sleepiness, cataplexy, excessive daytime sleepiness associated with narcolepsy, excessive daytime sleepiness associated with Parkinson's disease, excessive daytime sleepiness associated with multiple sclerosis, cataplexy associated with narcolepsy, fatigue, fatigue associated with Parkinson's diseases, fatigue associated with multiple sclerosis, or fibromyalgia in a patient comprising administering to a patient in need of said treatment a therapeutically effective amount of a pharmaceutical composition comprising:

an immediate release component, wherein the immediate release component comprises from 2 g to 7 g of 4-((L-valyl)oxy)butanoic acid; and

a modified release component, wherein the modified release component comprises from 7 g to 15 g of 4-((L-valyl)oxy)butanoic acid.