TREATMENT OF CIRCADIAN RHYTHM DISORDERS

• US 20140296330A1
• Filed: 06/11/2014
• Published: 10/02/2014
• Est. Priority Date: 01/26/2012
• Status: Active Grant

• Current Assignee: Vanda Pharmaceuticals Incorporated
• Original Assignee: Vanda Pharmaceuticals Incorporated
• Inventors: Dressman, Marlene Michelle, Feeney, John Joseph, Licamele, Louis William, Polymeropoulos, Mihael H.
• Granted Patent: US 9,060,995 B2
• Time in patent office: Days
• US Class Current: 514/469
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/15 Oximes (>C=N—O—); Hydrazines (>N—N<); Hydrazones (>N—N=) ; Imines (C—N=C)
• CPC Class Codes: A61K 31/277 having a ring, e.g. verapamil
• CPC Class Codes: A61K 31/343 condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• 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 25/26 Psychostimulants, e.g. nicotine, cocaine
• CPC Class Codes: A61P 27/00 Drugs for disorders of the senses
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/00 Drugs for disorders of the endocrine system
• CPC Class Codes: A61P 5/38 of the suprarenal hormones
• CPC Class Codes: G01N 2800/2864 Sleep disorders
• CPC Class Codes: G01N 30/7233 interfaced to liquid or supercritical fluid chromatograph interfaces in general for introducing or extracting samples to be analysed with specially adapted mass spectrometer, see H01J49/04
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere
• CPC Class Codes: G01N 33/74 involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

Embodiments of the invention relate to the use of a melatonin agonist in the treatment of free running circadian rhythms in patients, including light perception impaired patients, e.g., blind patients, and to methods of measuring circadian rhythm.

Claims

1-5. -5. (canceled)

6. A method of treating Non-24 in a patient suffering therefrom, said method comprising internally administering to the patient an effective amount of tasimelteon.

7. A method of entraining a patient suffering from Non-24 to a 24 hour sleep-wake cycle in which the patient awakens at or near a target wake time following a daily sleep period of approximately 7 to 9 hours, and maintaining said 24 hour sleep-wake cycle, said method comprising:

treating the patient by orally administering to the patient 20 mg of tasimelteon once daily before a target bedtime.

8. A method of treating a patient for a circadian rhythm disorder or for a sleep disorder wherein the patient is being treated with a strong CYP1A2 inhibitor, the method comprising:

(A) discontinuing the CYP1A2 inhibitor treatment and then

(B) treating the patient with tasimelteon,

thereby avoiding the use of tasimelteon in combination with a strong CYP1A2 inhibitor.

9. The method of claim 8, wherein the CYP1A2 inhibitor is fluvoxamine, ciprofloxacin, or verapamil.

10. The method of claim 8, wherein the CYP1A2 inhibitor is fluvoxamine.

11. The method of claim 10, that comprises treating the patient for Non-24-Hour Sleep-Wake Disorder.

12. The method of claim 11, wherein the patient is light perception impaired (LPI).

13. The method of claim 11, wherein treating the patient with tasimelteon comprises orally administering to the patient 20 mg of tasimelteon once daily before a target bedtime.

14. The method of claim 13, wherein the patient is entrained to a 24 hour sleep-wake cycle in which the patient awakens at or near a target wake time following a daily sleep period of approximately 7 to 9 hours.

15. A method of treating a patient for a circadian rhythm disorder or for a sleep disorder, the method comprising:

(i) if the patient is being treated with a strong CYP1A2 inhibitor, then

(A) maintaining the CYP1A2 inhibitor treatment and treating the patient for the circadian rhythm disorder or for the sleep disorder other than with tasimelteon or

(B) discontinuing the CYP1A2 inhibitor treatment and then treating the patient with tasimelteon,

thereby avoiding the use of tasimelteon in combination with a strong CYP1A2 inhibitor, and

(ii) if the patient is not being treated with a strong CYP1A2 inhibitor, then treating the patient with tasimelteon, thereby avoiding the use of tasimelteon in combination with a strong CYP1A2 inhibitor.

16. The method of claim 15, wherein the CYP1A2 inhibitor is fluvoxamine, ciprofloxacin, or verapamil.

17. The method of claim 15, wherein the CYP1A2 inhibitor is fluvoxamine.

18. The method of claim 16, that comprises treating the patient for Non-24-Hour Sleep-Wake Disorder wherein the patient is light perception impaired (LPI).

19. The method of claim 18, wherein the tasimelteon is administered at 0.5 to 1.5 hours before the target sleep time.

20. The method of claim 15, wherein the exposure to tasimelteon in a patient being treated with tasimelteon for a circadian rhythm disorder or for a sleep disorder is reduced by avoiding use of tasimelteon in combination with fluvoxamine.

21. The method of claim 15, wherein, if the patient is not being treated with fluvoxamine or if treatment with fluvoxamine is discontinued, then the patient is treated by oral administration of tasimelteon at 20 mg/day prior to bedtime.

22. The method of claim 21, that comprises treating the patient for Non-24-Hour Sleep-Wake Disorder.

23. A computing device comprising:

a processor;

a storage device comprising information that the patient is being treated with a CYP1A2 inhibitor;

an input device for inputting to either or both of the computing device or the storage device information that the patient will be prescribed a dose of tasimelteon;

a computer program operable to retrieve from the storage device the information that the patient is being treated with a CYP1A2 inhibitor upon inputting the information that the patient will be prescribed the dose of tasimelteon; and

an output device for outputting to a user the information that the patient is being treated with a CYP1A2 inhibitor.

24. The computing device of claim 23, wherein the CYP1A2 inhibitor is fluvoxamine.

25. The computing device of claim 24, wherein the storage device further comprises information about whether or not the patient is a smoker or whether or not the patient is being treated with a beta blocker or both whether or not the patient is a smoker and whether or not the patient is being treated with a beta blocker.