Claims for Patent: 11,426,373

Summary for Patent: 11,426,373

Title:	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Abstract:	Provided herein are pharmaceutical compositions and formulations comprising mixed salts of gamma-hydroxybutyrate (GHB). Also provided herein are methods of making the pharmaceutical compositions and formulations, and methods of their use for the treatment of sleep disorders such as apnea, sleep time disturbances, narcolepsy, cataplexy, sleep paralysis, hypnagogic hallucination, sleep arousal, insomnia, and nocturnal myoclonus.
Inventor(s):	Clark P. Allphin, Gunjan Junnarkar, Roman Skowronski, Cuiping Chen, Katayoun Zomorodi, Mark Eller
Assignee:	Jazz Pharmaceuticals Ireland Ltd
Application Number:	US17/131,418
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,426,373
Patent Claims:	1. A method of reducing food effect due to administration of gamma-hydroxybutyrate (GHB) in a patient having cataplexy in narcolepsy or excessive daytime sleepiness in narcolepsy, comprising: orally administering to a patient in need thereof a pharmaceutically effective amount of a pharmaceutical composition of GHB in a unit dosage comprising at least one salt of GHB and a pharmaceutically acceptable carrier within four hours after eating; wherein the pharmaceutical composition of GHB has reduced food effect as measured by Cmax compared to an equal dose of immediate release liquid solution of Na.GHB, wherein the pharmaceutical composition comprises: about 5% to about 10% of Na.GHB; about 20% to about 25% of K.GHB; about 45% to about 50% of Ca.(GHB)2; and about 20% to about 25% of Mg.(GHB)2. 2. The method of claim 1, wherein the composition is administered with food, immediately after eating, up to 30 minutes after eating, or up to two hours after eating. 3. The method of claim 1, wherein the composition provides an AUC when administered within four hours after eating that is 80%-95% of the AUC when the composition is administered while fasting. 4. The method of claim 1, wherein the composition provides an AUC when administered within four hours after eating that is 85%-90% of the AUC when the composition is administered while fasting. 5. The method of claim 1, wherein the composition provides a Cmax when administered within four hours after eating that is 55%-80% of the Cmax when the composition is administered while fasting. 6. The method of claim 1, wherein the composition provides a Cmax when administered within four hours after eating that is 60%-75% of the Cmax when the composition is administered while fasting. 7. The method of claim 1, wherein the composition provides a Cmax that is less than the Cmax of an equal dose of immediate release liquid solution of Na.GHB administered in equally divided doses at least four hours after eating. 8. The method of claim 1, wherein the composition provides a Cmax that is less than the Cmax of an equal dose of immediate release liquid solution of Na.GHB administered in equally divided doses within four hours after eating. 9. The method of claim 1, wherein the composition provides a Cmax that is less than 60% the Cmax of an equal dose of immediate release liquid solution of Na.GHB administered in equally divided doses at least four hours after eating. 10. The method of claim 1, wherein the composition provides a change in Cmax when administered at least four hours after eating and within four hours after eating that is 10-60% less than the change in Cmax of an equal dose of immediate release liquid solution of Na.GHB when administered in equally divided doses at least four hours after eating and within four hours after eating. 11. The method of claim 1, wherein the pharmaceutical composition comprises 8% of Na.GHB; 23% of K.GHB; 48% of Ca.(GHB)2; and 21% of Mg.(GHB)2.