Method of treatment

• US 10,610,511 B2
• Filed: 07/19/2019
• Issued: 04/07/2020
• Est. Priority Date: 11/12/2013
• Status: Active Grant

• Current Assignee: N/A
• Original Assignee: N/A
• Inventors: Dressman, Marlene Michelle, Polymeropoulos, Mihael H., Baroldi, Paolo
• Primary Examiner(s): Podgorski, Daniel M
• Application Number:
  US16/517,111
• Publication Number:
  US 20190336470A1
• Time in Patent Office: 263 Days
• Field of Search: None
• CPC Class Codes: A61K 31/343 condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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.

Claims

1. A method of treating a human patient suffering from a circadian rhythm disorder or a sleep disorder, the method comprising:

instructing the patient that tasimelteon should be taken without food; and

orally administering to the patient an effective dose of tasimelteon without food.

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

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

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

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

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

11. The method of claim 1, wherein the effective dose is 20 mg/d.

12. In a method of treating a human patient suffering from a circadian rhythm disorder or a sleep disorder by orally administering to the patient 20 mg/d of tasimelteon once daily before a target bedtime, the improvement comprising:

instructing the patient that tasimelteon should be taken without food,

wherein the patient has had no food for at least ½

hour prior to the administering.

13. The improvement of claim 12, wherein the patient has had no food for at least one hour prior to the administering.

14. The improvement of claim 12, wherein the patient has had no food for at least one-and-one-half hours prior to the administering.

15. The improvement of claim 12, wherein the patient has had no food for at least two hours prior to the administering.

16. The improvement of claim 12, wherein the patient has had no food for at least two-and-one-half hours prior to the administering.

17. The improvement of claim 12, wherein the patient has had no food for at least three hours prior to the administering.

18. A method of treating a human patient suffering from a circadian rhythm disorder or a sleep disorder that comprises instructing the patient that tasimelteon should be taken without food before orally administering to the patient an effective dose of tasimelteon without food.

19. The method of claim 18, wherein the effective dose is 20 mg/d.