You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 19, 2025

Claims for Patent: 11,000,498

✉ Email this page to a colleague

« Back to Dashboard

Summary for Patent: 11,000,498

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, Julien Grassot
Assignee:	Flamel Ireland Ltd
Application Number:	US16/431,219
Patent Claims:	1. An oral pharmaceutical composition for the treatment of narcolepsy, cataplexy, or excessive daytime sleepiness comprising gamma-hydroxybutyrate in a unit dose suitable for administration once daily to a human patient in need thereof, wherein the composition is dose proportional. 2. The oral pharmaceutical composition of claim 1, wherein the composition is suitable for administration in the evening. 3. The oral pharmaceutical composition of claim 1, wherein the composition is suitable for administration in the morning. 4. The oral pharmaceutical composition of claim 1, wherein the composition is dose proportional across 4.5 g, 7.5 g, and 9 g doses of the composition. 5. The oral pharmaceutical composition of claim 1, wherein the Cmax of the composition is proportional across 4.5 g, 7.5 g, and 9 g doses of the composition. 6. The oral pharmaceutical composition of claim 1, wherein the composition is dose proportional by a factor of 1 to 1.3. 7. The oral pharmaceutical composition of claim 4, wherein median Tmax is between about 1.5 and 2 hours across the increasing doses. 8. The oral pharmaceutical composition of claim 1, wherein the mean Cmax is between about 42.9 and 84.5 μg/mL across the increasing doses. 9. The oral pharmaceutical composition of claim 4, wherein the mean AUCinf is about 191, 358 and 443 μg·h/mL for the 4.5, 7.5 and 9 g doses, respectively. 10. The oral pharmaceutical composition of claim 4, wherein the mean concentrations at 8 hours are about 4.8, 19.7 and 25.5 μg/mL for the 4.5, 7.5 and 9 g doses, respectively. 11. A method of treating narcolepsy and associated disorders and symptoms in a patient in need thereof comprising: administering an oral pharmaceutical composition comprising gamma-hydroxybutyrate once daily to a human patient in need thereof, wherein the composition is dose proportional. 12. The method of claim 11, wherein the composition is administered in the evening. 13. The method of claim 11, wherein the composition is administered in the morning. 14. The method of claim 11, wherein the composition is dose proportional across 4.5 g, 7.5 g, and 9 g doses of the composition. 15. The method of claim 11, wherein the Cmax of the composition is proportional across 4.5 g, 7.5 g, and 9 g doses of the composition. 16. The method of claim 11, wherein the composition is dose proportional by a factor of 1 to 1.3. 17. The method of claim 14, wherein median Tmax is between about 1.5 and 2 hours across the increasing doses. 18. The method of claim 14, wherein the mean Cmax is between about 42.9 and 84.5 μg/mL across the increasing doses. 19. The method of claim 14, wherein the mean AUCinf is about 191, 358 and 443 μg·h/mL for the 4.5, 7.5 and 9 g doses, respectively. 20. The method of claim 14, wherein the mean concentrations at 8 hours are about 4.8, 19.7 and 25.5 μg/mL for the 4.5, 7.5 and 9 g doses, respectively.

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.