Claims for Patent: 10,925,844

Summary for Patent: 10,925,844

Title:	Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
Abstract:	Oral pharmaceutical compositions of sodium oxybate having improved pharmacokinetic properties when administered less than two hours after eating are provided, and therapeutic uses thereof.
Inventor(s):	Grassot Julien, Grangeon Cendrine, Dubow Jordan
Assignee:	Flamel Ireland Limited
Application Number:	US16987510
Patent Claims:	2. The oral pharmaceutical composition of claim 1 , wherein the composition is suitable for administrating with food claim 1 , immediately after eating claim 1 , up to 30 minutes after eating claim 1 , up to 1 hours after eating claim 1 , or up to 1.5 hours after eating.3. The oral pharmaceutical composition of claim 1 , wherein the composition is administered once daily.4. The oral pharmaceutical composition of claim 1 , wherein the composition is suitable for administration in the evening.5. The oral pharmaceutical composition of claim 1 , wherein the composition is suitable for administration in the morning.6. The oral pharmaceutical composition of claim 1 , wherein the composition comprises gamma-hydroxybutyrate in an extended release or delayed release formulation.7. The oral pharmaceutical composition of claim 1 , wherein the composition comprises gamma-hydroxybutyrate in a modified release formulation.8. The oral pharmaceutical composition of claim 1 , wherein the composition provides a substantially similar fed state PK profile and 2 hours post meal administration PK profile.9. The oral pharmaceutical composition of claim 1 , wherein the composition provides a mean AUCwhen administered less than two hours after eating that is 50%-120% of the mean AUCwhen the composition is administered at least two hours after eating.10. The oral pharmaceutical composition of claim 1 , wherein the composition provides a mean AUCwhen administered less than two hours after eating that is 50%-120% of the mean AUCwhen the composition is administered while fasting.11. The oral pharmaceutical composition of claim 10 , wherein the composition provides a mean AUCwhen administered less than two hours after eating that is 80%-95% of the mean AUCwhen the composition is administered while fasting.12. The oral pharmaceutical composition of claim 11 , wherein the composition provides a mean AUCwhen administered less than two hours after eating that is 85%-90% of the mean AUCwhen the composition is administered while fasting.13. The oral pharmaceutical composition of claim 1 , wherein the composition provides a mean Cwhen administered less than two hours after eating that is 50%-120% of the mean Cwhen the composition is administered at least two hours after eating.14. The oral pharmaceutical composition of claim 1 , wherein the composition provides a mean Cwhen administered less than two hours after eating that is 50%-120% of the mean Cwhen the composition is administered while fasting.15. The oral pharmaceutical composition of claim 14 , wherein the composition provides a mean Cwhen administered less than two hours after eating that is 55%-80% of the mean Cwhen the composition is administered while fasting.16. The oral pharmaceutical composition of claim 15 , wherein the composition provides a mean Cwhen administered less than two hours after eating that is 60%-75% of the mean Cwhen the composition is administered while fasting.17. The oral pharmaceutical composition of claim 1 , wherein the composition provides a Cthat is dose proportional.18. The oral pharmaceutical composition of claim 1 , wherein the composition provides no dose dumping.19. The oral pharmaceutical composition of claim 1 , wherein there is no significant reduction in safety or efficacy to a patient following administration.20. The oral pharmaceutical composition of claim 1 , wherein the composition provides an AUCbioequivalent to an AUCof an equal dose of immediate release liquid solution of sodium oxybate administered at to and to in equally divided doses at least two hours after eating.21. The oral pharmaceutical composition of claim 1 , wherein the composition provides a Cthat is less than the Cof an equal dose of immediate release liquid solution of sodium oxybate administered at to and to in equally divided doses at least two hours after eating.22. The oral pharmaceutical composition of claim 1 , wherein the composition provides a Cthat is less than the Cof an equal dose of immediate release liquid solution of sodium oxybate administered at to and to in equally divided doses less than two hours after eating.23. The oral pharmaceutical composition of claim 1 , wherein the composition provides a Cthat is 10-60% less than the Cof an equal dose of immediate release liquid solution of sodium oxybate administered at to and to in equally divided doses at least two hours after eating.24. The oral pharmaceutical composition of claim 1 , wherein the composition provides a Cthat is 10-60% less than the Cof an equal dose of immediate release liquid solution of sodium oxybate administered at to and to in equally divided doses less than two hours after eating.25. The oral pharmaceutical composition of claim 1 , wherein the composition provides a change in Cbetween when the composition is administered at least two hours after eating and when the composition is administered less than two hours after eating that is 10-60% less than the change in Cof an equal dose of immediate release liquid solution of sodium oxybate administered at to and to in equally divided doses at least two hours after eating.26. The oral pharmaceutical composition of claim 1 , wherein the composition provides a change in Cbetween when the composition is administered at least two hours after eating and when the composition is administered less than two hours after eating that is 10-60% less than the change in Cof an equal dose of immediate release liquid solution of sodium oxybate administered at to and to in equally divided doses less than two hours after eating.27. The oral pharmaceutical composition of claim 1 , wherein the composition provides an AUC that is more dose proportional than the AUC of an equal dose of immediate release liquid solution of sodium oxybate administered at tand tin equally divided doses at least two hours after eating.28. The oral pharmaceutical composition of claim 1 , wherein the composition provides an AUC that is more dose proportional than the AUC of an equal dose of immediate release liquid solution of sodium oxybate administered at tand tin equally divided doses less than two hours after eating.