Claims for Patent: 10,952,986

Summary for Patent: 10,952,986

Title:	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Abstract:	Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.
Inventor(s):	Claire Megret, Herve Guillard, Jean-Francois Dubuisson
Assignee:	Flamel Ireland Ltd
Application Number:	US16/420,321
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,952,986
Patent Claims:	1. A method of treating a disorder treatable with gamma-hydroxybutyrate in a human in need thereof, the method comprising: administering a single daily dose to said human, the single daily dose comprising an amount of gamma-hydroxybutyrate equivalent to from 3.0 to 12.0 g of sodium oxybate, wherein the administering comprises opening a sachet containing a gamma-hydroxybutyrate formulation, mixing the formulation with water, and orally administering the mixture. 2. The method of claim 1, wherein the orally administering occurs at bedtime. 3. The method of claim 1, wherein the mixing occurs shortly before the orally administering. 4. The method of claim 1, wherein the orally administering occurs approximately 2 hours after said human has eaten a meal. 5. The method of claim 1, wherein said administering results in inducing said human to sleep for 6 to 8 hours. 6. The method of claim 1, wherein the amount of gamma-hydroxybutyrate administered to the human is equivalent to 4.5 g, 6.0 g, 7.5 g, or 9.0 g of sodium oxybate. 7. The method of claim 1, wherein the mixture is a suspension. 8. The method of claim 1, wherein the mixing comprises pouring the gamma-hydroxybutyrate formulation from the sachet into a container containing the water. 9. The method of claim 8, wherein the container contains 50 mL of water prior to the pouring. 10. A method of treating a disorder treatable with gamma-hydroxybutyrate in a human in need thereof, the method comprising: administering a 4.5 g dose of gamma-hydroxybutyrate to said human that yields a pharmacokinetic profile as shown in FIG. 11, wherein the dose comprises immediate release and modified release portions. 11. A method of treating a disorder treatable with gamma-hydroxybutyrate in a human in need thereof, the method comprising: administering a modified release formulation of gamma-hydroxybutyrate, comprising immediate release and modified release portions, at a dose of 4.5 g, 6.0 g, or 7.5 g approximately two hours after a standardized evening meal that yields a plasma concentration versus time curve bioequivalent to that depicted in FIG. 12. 12. A method of treating a disorder treatable with gamma-hydroxybutyrate in a human in need thereof, the method comprising: administering a modified release formulation of gamma-hydroxybutyrate, comprising immediate release and modified release portions, at a dose of 4.5 g, 6.0 g, or 7.5 g approximately two hours after a standardized evening meal that yields a plasma concentration versus time curve bioequivalent to that depicted in FIG. 13. 13. A method of treating narcolepsy Type 1 or Type 2, the method comprising: administering a single daily dose to a human in need thereof, the single daily dose comprising an amount of gamma-hydroxybutyrate equivalent to from 3.0 to 12.0 g of sodium oxybate, wherein the administering comprises opening a sachet containing a gamma-hydroxybutyrate formulation, mixing the formulation with water, and orally administering the mixture. 14. The method of claim 13, wherein the orally administering occurs at bedtime. 15. The method of claim 13, wherein the mixing occurs shortly before the orally administering. 16. The method of claim 13, wherein the orally administering occurs approximately 2 hours after said human has eaten a meal. 17. The method of claim 13, wherein said administering results in inducing said human to sleep for 6 to 8 hours. 18. The method of claim 13, wherein the amount of gamma-hydroxybutyrate administered to the human is equivalent to 4.5 g, 6.0 g, 7.5 g, or 9.0 g of sodium oxybate. 19. The method of claim 13, wherein the mixture is a suspension. 20. The method of claim 13, wherein the mixing comprises pouring the gamma-hydroxybutyrate formulation from the sachet into a container containing the water. 21. The method of claim 20, wherein the container contains 50 mL of water prior to the pouring. 22. A method of treatment of narcolepsy Type 1 or Type 2, the method comprising: administering a single daily dose to a human in need thereof, the single daily dose comprising an amount of gamma-hydroxybutyrate equivalent to from 3.0 to 12.0 g of sodium oxybate, wherein, compared to a dosing regimen consisting of administering half the dose at t0 and another half of the dose at t4h of an immediate release liquid solution of sodium oxybate, the method produces less confusion, less depressive syndrome, less incontinence, less nausea, or less sleepwalking. 23. A method of reducing narcolepsy-related excessive daytime sleepiness or frequency of cataplectic attacks, the method comprising: administering a single daily dose to a human in need thereof, the single daily dose comprising an amount of gamma-hydroxybutyrate equivalent to from 3.0 to 12.0 g of sodium oxybate, wherein the administering comprises opening a sachet containing a gamma-hydroxybutyrate formulation, mixing the formulation with water, and orally administering the mixture. 24. The method of claim 23, wherein the orally administering occurs at bedtime. 25. The method of claim 23, wherein the mixing occurs shortly before the orally administering. 26. The method of claim 23, wherein the orally administering occurs approximately 2 hours after said human has eaten a meal. 27. The method of claim 23, wherein said administering results in inducing said human to sleep for 6 to 8 hours. 28. The method of claim 23, wherein the amount of gamma-hydroxybutyrate administered to the human is equivalent to 4.5 g, 6.0 g, 7.5 g, or 9.0 g of sodium oxybate. 29. The method of claim 23, wherein the mixture is a suspension. 30. The method of claim 23, wherein the mixing comprises pouring the gamma-hydroxybutyrate formulation from the sachet into a container containing the water. 31. The method of claim 30, wherein the container contains 50 mL of water prior to the pouring.