Method of treatment

Patent metadata

Field	Value
Publication number	US-10376487-B2
Application number	US-201414511669-A
Country	US
Kind code	B2
Filing date	Oct 10, 2014
Priority date	Nov 12, 2013
Publication date	Aug 13, 2019
Grant date	Aug 13, 2019

Abstract

One embodiment of the invention provides a method for administering tasimelteon to a human patient that comprises orally administering an effective dose of tasimelteon under fasted conditions. Fasted conditions may comprise administering the tasimelteon without food, no food at least ½ hour prior to administration, no food at least 1 hour prior to administration, no food at least 1½ hours prior to administration, no food at least 2 hours prior to administration, no food at least 2½ hours prior to administration, or no food at least 3 hours prior to administration. According to such embodiments, tasimelteon may be administered, for example, at a dose of 20 mg/d. Tasimelteon may be administered where, for example, the patient is being treated for a circadian rhythm disorder or for a sleep disorder, including, for example, Non-24 Disorder.

First claim

What is claimed is:

1. A method of treating a human patient suffering from a circadian rhythm disorder or a sleep disorder that comprises orally administering to the patient an effective dose of tasimelteon without food, wherein the effective dose is 20 mg/d.

2. The method of claim 1 , wherein the tasimelteon is administered with no food after at least ½ hour prior to administration.

3. The method of claim 1 , wherein C max of the tasimelteon is lowered while AUC is approximately the same whether the tasimelteon is administered under fed conditions or under fasted conditions.

4. The method of claim 1 , wherein the patient is suffering from a circadian rhythm disorder.

5. The method of claim 4 , wherein the circadian rhythm disorder is Non-24 Disorder.

6. The method for shortening T max in a human patient suffering from a circadian rhythm disorder or a sleep disorder and being treated with tasimelteon, said method comprising orally administering an effective dose of tasimelteon without food, wherein the effective dose is 20 mg/d.

7. The method of claim 6 , wherein the tasimelteon is administered with no food after at least ½ hour prior to administration.

8. The method of claim 6 , wherein C max of the tasimelteon is lowered while AUC is approximately the same whether the tasimelteon is administered under fed conditions or under fasted conditions.

9. The method of claim 6 , wherein the patient is suffering from a circadian rhythm disorder.

10. The method of claim 9 , wherein the circadian rhythm disorder is Non-24 Disorder.

11. The method of claim 1 , wherein the tasimelteon is administered with no food after at least one hour prior to administration.

12. The method of claim 1 , wherein the tasimelteon is administered with no food after at least one-and-one-half hours prior to administration.

13. The method of claim 1 , wherein the tasimelteon is administered with no food after at least two hours prior to administration.

14. The method of claim 1 , wherein the tasimelteon is administered with no food after at least two-and-one-half hours prior to administration.

15. The method of claim 1 , wherein the tasimelteon is administered with no food after at least three hours prior to administration.

16. The method of claim 6 , wherein the tasimelteon is administered with no food after at least one hour prior to administration.

17. The method of claim 6 , wherein the tasimelteon is administered with no food after at least one-and-one-half hours prior to administration.

18. The method of claim 6 , wherein the tasimelteon is administered with no food after at least two hours prior to administration.

19. The method of claim 6 , wherein the tasimelteon is administered with no food after at least two-and-one-half hours prior to administration.

20. The method of claim 6 , wherein the tasimelteon is administered with no food after at least three hours prior to administration.

Assignees

• Vanda Pharmaceuticals Inc

Inventors

• Dressman Marlene Michelle
• Polymeropoulos Mihael H
• Baroldi Paolo

Classifications

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P25/20

  Hypnotics; Sedatives · CPC title

• A61P25/00

  Drugs for disorders of the nervous system · CPC title

• A61K31/343 Primary

  condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone · CPC title

• A61K9/0053

  Mouth and digestive tract, i.e. intraoral and peroral administration · CPC title