IP Library › Granted Patent US 12,478,604
Granted Patent B1
US 12,478,604 · App. 17/966,538 · Granted Nov 25, 2025

Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics

Inventors: Jordan Dubow (Lyons, FR); Claire Megret (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 12,478,604
App. No.
17/966,538
Granted
Nov 25, 2025
Kind
B1
Abstract

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

Claims (17)

1 . A method of treating cataplexy, disturbed nocturnal sleep, or excessive daytime sleepiness in a human patient with narcolepsy, the method comprising:

orally administering only once per day to the patient a formulation that releases gamma-hydroxybutyrate (GHB) from a source of GHB into the bloodstream of the patient, wherein the formulation comprises an immediate-release portion and a modified-release portion, and wherein an amount of GHB released into the bloodstream of the patient is equivalent to 3.0-12.0 g of sodium oxybate; and

repeating the orally administering daily, wherein the patient experiences a decrease in body weight due, at least in part, to the repeating.

2 . The method of claim 1 , wherein the decrease in body weight is statistically significant.

3 . The method of claim 1 , wherein the patient experiences a ≥5% decrease in body weight.

4 . The method of claim 1 , wherein the patient experiences a decrease in body mass index (BMI) due, at least in part, to the repeating.

5 . The method of claim 4 , wherein the patient experiences a ≥0.5 decrease in BMI.

6 . The method of claim 1 , wherein the decrease in body weight occurs after at least 13 days of the repeating.

7 . The method of claim 6 , wherein the amount of gamma-hydroxybutyrate released into the bloodstream of the patient is equivalent to 6 g of sodium oxybate.

8 . The method of claim 1 , wherein the decrease in body weight occurs after at least 20 days of the repeating.

9 . The method of claim 1 , wherein the decrease in body weight occurs after at least 55 days of the repeating.

10 . The method of claim 1 , wherein the decrease in body weight occurs after at least 27 days of the repeating.

11 . The method of claim 1 , wherein the decrease in body weight occurs after at least 62 days of the repeating.

12 . The method of claim 1 , wherein the decrease in body weight occurs after at least 90 days of the repeating.

13 . The method of claim 1 , wherein the formulation comprises one or more tautomers, salts, hydrates, solvates or complexes of gamma-hydroxybutyrate.

14 . The method of claim 1 , wherein the modified-release portion comprises a delayed-release portion.

15 . The method of claim 1 , wherein the modified-portion comprises an extended release portion.

Assignments (3)
RELEASE OF SECURITY INTEREST Recorded May 21, 2026
From: RTW INVESTMENTS, LP, AS COLLATERAL AGENT
To: AVADEL CNS PHARMACEUTICALS, LLC; FLAMEL IRELAND LTD.
Reel/Frame 074729/0205 →
PATENT COLLATERAL AGREEMENT Recorded Aug 1, 2023
From: AVADEL CNS PHARMACEUTICALS, LLC; FLAMEL IRELAND LTD.
To: RTW INVESTMENTS, LP
Reel/Frame 064463/0907 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 2, 2023
From: DUBOW, JORDAN; MÉGRET, CLAIRE; GUILLARD, HERVÉ; DUBUISSON, JEAN-FRANÇOIS
To: FLAMEL IRELAND LIMITED
Reel/Frame 062858/0001 →
Continuity (9)
Continuation In Part 17497366 · Oct 8, 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 63255755 · Oct 14, 2021
Provisional Application 62474330 · Mar 21, 2017
Provisional Application 62399413 · Sep 25, 2016
Provisional Application 62365812 · Jul 22, 2016
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