IP Library › Granted Patent US 12,263,151
Granted Patent B2
US 12,263,151 · App. 18/889,055 · Granted Apr 1, 2025

Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics

Inventors: Claire Mégret (Lyons, FR); Hervé Guillard (Villeurbanne, FR); Jean-François Dubuisson (Lyons, FR)
Assignee: Flamel Ireland Limited
A61K31/22A61K9/14A61K9/1676A61K9/5015A61K9/5026A61K9/5042A61K9/5078A61K9/5084A61K31/19
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Quick Facts
Patent No.
US 12,263,151
App. No.
18/889,055
Granted
Apr 1, 2025
Kind
B2
Abstract

Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.

Claims (37)

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.

2. The method of claim 1 , wherein the formulation achieves a mean C8h of:

from 5.4 to 8.3 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 4.5 g of sodium oxybate,

from 7.3 to 15.4 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 6.0 g of sodium oxybate, or

from 16.0 to 26.0 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 7.5 g of sodium oxybate.

3. The method of claim 1 , wherein the formulation achieves a mean C8h of:

from 6.1 to 7.6 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 4.5 g of sodium oxybate,

from 8.2 to 14.1 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 6.0 g of sodium oxybate, or

from 15.0 to 25.0 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 7.5 g of sodium oxybate.

4. The method of claim 1 , wherein the formulation achieves a mean C8h of:

from 3.5 to 7.0 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 4.5 g of sodium oxybate,

from 8.9 to 16.7 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 6.0 g of sodium oxybate, or

from 17.5 to 22.0 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 7.5 g of sodium oxybate.

5. The method of claim 1 , wherein the formulation achieves a mean C8h of:

from 4.0 to 5.5 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 4.5 g of sodium oxybate,

from 10.2 to 15.4 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 6.0 g of sodium oxybate, or

from 21.6 to 40.3 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 7.5 g of sodium oxybate.

6. The method of claim 1 , wherein the formulation achieves a mean C8h of:

from 11.5 to 14.1 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 6.0 g of sodium oxybate, or

from 24.7 to 37.2 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 7.5 g of sodium oxybate.

7. The method of claim 1 , wherein the immediate release portion of the formulation releases at least 90% of its gamma-hydroxybutyrate into the blood stream of the patient within 3 hours after the orally administering.

8. The method of claim 1 , wherein at least 90% of the gamma-hydroxybutyrate of the formulation is released into the blood stream of the patient within 8 hours after the orally administering.

9. The method of claim 1 , further comprising inducing the patient to sleep six to eight consecutive hours due, at least in part, to the release of the gamma-hydroxybutyrate into the blood stream of the patient.

10. The method of claim 1 , further comprising inducing the patient to sleep eight consecutive hours due, at least in part, to the release of the gamma-hydroxybutyrate into the blood stream of the patient.

11. The method of claim 1 , further comprising opening a nightly dose packet containing the formulation, wherein the opening occurs prior to the orally administering.

12. The method of claim 1 , wherein the formulation is a powder for oral suspension.

13. The method of claim 1 , wherein the formulation achieves a Tmax of 1.25 to 3.25 hours.

14. The method of claim 1 , wherein the orally administering occurs at least two hours after the patient eating a meal.

15. The method of claim 1 , wherein the orally administering occurs approximately two hours after a standardized evening meal.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 31, 2024
From: MÉGRET, CLAIRE; GUILLARD, HERVÉ; DUBUISSON, JEAN-FRANÇOIS
To: FLAMEL IRELAND LIMITED
Reel/Frame 069710/0584 →
Continuity (11)
Continuation 18759320 · Jun 28, 2024
Continuation 18643773 · Apr 23, 2024
Continuation 17530096 · Nov 18, 2021
Continuation In Part 17178117 · Feb 17, 2021
Continuation In Part 16527633 · Jul 31, 2019
Continuation 16281235 · Feb 21, 2019
Continuation 15655924 · Jul 21, 2017
Provisional Application 62474330 · Mar 21, 2017
Provisional Application 62399413 · Sep 25, 2016
Provisional Application 62365812 · Jul 22, 2016
Related Publication 20250009705A1 · Jan 9, 2025
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