Granted Patent
B2
US 12,582,622 · App. 18/248,499 · Granted Mar 24, 2026
Sodium oxybate to treat idiopathic hypersomnia
Inventors:
Franck Skobieranda (Palo Alto, CA); Dan Chen (Palo Alto, CA); Amanda Leigh Sterkel (Palo Alto, CA)
Assignee:
JAZZ PHARMACEUTICALS IRELAND LIMITED
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Abstract
The present disclosure relates to methods of treating idiopathic hypersomnia with oxybate, preferably sodium oxybate.
Claims (36)
1 . A method of treating idiopathic hypersomnia in a patient in need thereof, the method comprising:
administering a therapeutically effective amount of sodium oxybate to the patient.
2 . A method of treating idiopathic hypersomnia in a patient in need thereof, the method comprising:
administering a therapeutically effective amount of sodium oxybate to the patient,
wherein the sodium oxybate is administered as a liquid and the concentration of sodium oxybate in the liquid is about 500 mg/mL.
3 . The method of claim 1 , wherein the sodium oxybate is administered as a liquid, and the concentration of the sodium oxybate in the liquid is from 350 mg/ml-650 mg/ml.
4 . The method of claim 1 , wherein the method comprises:
(a) administering an initial daily dose of the sodium oxybate to the patient and
(b) titrating the dose to provide the therapeutically effective amount of the sodium oxybate.
5 . The method of claim 4 , wherein the initial daily dose is from about 3 g to about 4.5 g of the sodium oxybate.
6 . The method of claim 4 , wherein the titration step (b) comprises administering ascending doses of the sodium oxybate.
7 . The method of claim 1 , wherein about 4.5 g to 9.0 g of the sodium oxybate is administered per day.
8 . The method of claim 1 , wherein the sodium oxybate is administered twice per day or once a day.
9 . The method of claim 1 , wherein about 4.5 g, about 6 g, about 7.5 g, or about 9 g of the sodium oxybate is administered per day.
10 . The method of claim 1 , wherein about 3 g, about 3.75 g, or about 4.5 g of the sodium oxybate is administered per day.
11 . The method of claim 1 , wherein the sodium oxybate is administered at bedtime.
12 . The method of claim 2 , wherein the method comprises:
(a) administering an initial daily dose of the sodium oxybate to the patient and
(b) titrating the dose to provide a therapeutically effective amount of the sodium oxybate.
13 . The method of claim 12 , wherein the initial daily dose is from about 0.5 g to about 4.5 g of the sodium oxybate administered per day.
14 . The method of claim 12 , wherein the titration step (b) comprises administering ascending doses of the sodium oxybate.
15 . The method of claim 14 , wherein dose is increased by about 0.5 g to 1.5 g per week.
16 . The method of 12 , wherein the titration step (b) comprises administering descending doses of the sodium oxybate.
17 . The method of claim 16 , wherein dose is decreased by about 0.5 g to 9.0 g per week.
18 . The method of claim 12 , wherein the titration step (b) comprises switching a patient from a once a day dose to a twice a day dose of the sodium oxybate.
19 . The method of claim 12 , wherein the titration step (b) comprises switching a patient from a twice a day dose to a three times a day, or a once a day dose of the sodium oxybate.
20 . The method of claim 2 , wherein about 0.25 g-10.0 g of the sodium oxybate is administered per day.
21 . The method of claim 4 , wherein the initial daily dose is 4.5 g of sodium oxybate, and the dose is titrated to 6 g to 9 g of sodium oxybate per night.
22 . The method of claim 4 , wherein the sodium oxybate is in a mixed salt oxybate.
23 . The method of claim 22 , wherein the mixed salt oxybate comprises sodium oxybate, calcium oxybate, potassium oxybate, and magnesium oxybate.
24 . The method of claim 23 , wherein the mixed salt oxybate comprises about 8% sodium oxybate, about 23% potassium oxybate, about 21% magnesium oxybate, and about 48% calcium oxybate (% mol. eq.).
25 . The method of claim 22 , wherein the initial daily dose is 3.0 g of mixed salt oxybate, and the dose is titrated to 4.5 g to 9 g of mixed salt oxybate per night.
26 . The method of claim 21 , wherein the sodium oxybate is provided in a solid formulation.
27 . The method of claim 21 , wherein the sodium oxybate is present in a sustained release oxybate composition.
28 . The method of claim 21 , wherein the sodium oxybate is administered once daily.
29 . The method of claim 22 , wherein the mixed oxybate is administered once daily or twice daily.
Assignments (2)
SECURITY AGREEMENT
Recorded Jul 26, 2024
From: CAVION, INC.; CELATOR PHARMACEUTICALS, INC.; GW PHARMA LIMITED; JAZZ PHARMACEUTICALS, INC.; JAZZ PHARMACEUTICALS IRELAND LIMITED; JAZZ PHARMACEUTICALS RESEARCH UK LIMITED (F/K/A GW RESEARCH LIMITED)
To: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION, AS COLLATERAL TRUSTEE
Reel/Frame 068173/0155 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 20, 2023
From: SKOBIERANDA, FRANCK; CHEN, DAN; STERKEL, AMANDA LEIGH
To: JAZZ PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 063389/0471 →
Continuity (2)
Provisional Application
63089428
· Oct 8, 2020
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