Ultra low dose doxepin and methods of using the same to treat sleep disorders

• US 10,507,193 B2
• Filed: 03/05/2018
• Issued: 12/17/2019
• Est. Priority Date: 10/25/2006
• Status: Active Grant

• Current Assignee: Currax Pharmaceuticals, LLC (Currax Holdings USA, LLC)
• Original Assignee: Currax Pharmaceuticals, LLC (Currax Holdings USA, LLC)
• Inventors: Jochelson, Philip, Kavey, Neil B.
• Primary Examiner(s): Chernyshev, Olga N
• Application Number:
  US15/911,832
• Publication Number:
  US 20180193302A1
• Time in Patent Office: 652 Days
• Field of Search: None
• 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 31/335 having oxygen as the only ring hetero atom, e.g. fungichromin
• CPC Class Codes: A61K 31/343 condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
• CPC Class Codes: A61K 31/4162 condensed with heterocyclic ring systems
• CPC Class Codes: A61K 31/437 the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
• CPC Class Codes: A61K 31/4535 containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
• CPC Class Codes: A61K 31/4985 Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
• CPC Class Codes: A61K 31/505 Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
• CPC Class Codes: A61K 31/55 having seven-membered rings, e.g. azelastine, pentylenetetrazole
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives

Abstract

The invention relates to doxepin, pharmaceutically acceptable salts and prodrugs of doxepin; compositions containing the same, and the use of any of the aforementioned for the treatment of sleep disorders.

Claims

1. A composition comprising doxepin, or a pharmaceutically acceptable salt thereof in a dosage of about 0.0001 milligrams to about 0.4 milligrams.

2. The composition of claim 1, further comprising a pharmaceutically acceptable carrier.

3. The composition of claim 1, wherein the pharmaceutically acceptable salt of doxepin is the hydrochloride salt thereof.

4. The composition of claim 1, comprising a dosage of about 0.001 to about 0.1 milligrams of doxepin, or a pharmaceutically acceptable salt of doxepin.

5. The composition of claim 1, comprising a dosage of about 0.01 to about 0.099 milligrams of doxepin, or a pharmaceutically acceptable salt of doxepin.

6. The composition of claim 1, wherein the composition is in a form suitable for oral or nasal administration.

7. The composition of claim 1, further comprising at least one of ramelteon, eszopiclone, zolpidem tartrate, or zaleplon.

8. The composition of claim 1, further comprising at least one additional sleep medication.

9. The composition of claim 8, Wherein the at least one additional sleep medication is selected from a 5-HT2 antagonist, ketanserin, a H3 agonist, an orexin antagonist, a noradrenergic antagonist, a galanin agonist, a CRH antagonist, Gaboxadol, a GABA-A direct antagonist, a GABA reuptake inhibitor, tiagabine, a growth hormone, a growth hormone agonist, estrogen, an estrogen agonist, or a melatonin agonist.