Claims for Patent: 10,376,487

Summary for Patent: 10,376,487

Title:	Method of treatment
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 1/2 hour prior to administration, no food at least 1 hour prior to administration, no food at least 11/2 hours prior to administration, no food at least 2 hours prior to administration, no food at least 21/2 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.
Inventor(s):	Dressman; Marlene Michelle (Germantown, MD), Polymeropoulos; Mihael H. (Potomac, MD), Baroldi; Paolo (Potomac, MD)
Assignee:	Vanda Pharmaceuticals Inc. (Washington, DC)
Application Number:	14/511,669
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,376,487
Patent Claims:	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 1/2 hour prior to administration. 3. The method of claim 1, wherein C.sub.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.sub.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 1/2 hour prior to administration. 8. The method of claim 6, wherein C.sub.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.