Method of treating thermoregulatory dysfunction with paroxetine

• US 8,946,251 B2
• Filed: 01/17/2014
• Issued: 02/03/2015
• Est. Priority Date: 08/04/2006
• Status: Active Grant

• Current Assignee: Sebela Ireland Limited (Sebela International Limited)
• Original Assignee: Noven Therapeutics LLC (Hisamitsu Pharmaceutical Company Incorporated)
• Inventors: Richards, Patricia Allison Tewes
• Primary Examiner(s): Claytor, Renee
• Assistant Examiner(s): Kantamneni, Shobha
• Application Number:
  US14/157,992
• Publication Number:
  US 20140235674A1
• Time in Patent Office: 382 Days
• US Class Current: 514/277
• CPC Class Codes: A61K 31/4525 containing a five-membered ring with oxygen as a ring hetero atom
• CPC Class Codes: A61P 15/12 for climacteric disorders
• CPC Class Codes: A61P 5/24 of the sex hormones

Abstract

The present invention relates to a method for treating a patient suffering from a thermoregulatory dysfunction, especially hot flashes and flushes associated with hormonal changes due to naturally occurring menopause (whether male or female) or due to chemically or surgically induced menopause. The method is also applicable to treating the hot flashes, hot flushes, or night sweats associated with disease states that disrupt normal hormonal regulation of body temperature.

Claims

1. A method for treating a patient suffering from a thermoregulatory dysfunction associated with menopause, comprising administering a dosage form of paroxetine to said patient in an amount, based on the paroxetine moiety, of 7.5 mg/day.

2. The method of claim 1, wherein said thermoregulatory dysfunction is a condition selected from the group consisting of hot flashes, hot flushes, night sweats and combinations thereof.

3. The method of claim 1, wherein the dosage form comprises paroxetine free base.

4. The method of claim 1, wherein the dosage form comprises a pharmaceutically acceptable salt of paroxetine.

5. The method of claim 1, wherein the dosage form comprises a pharmaceutically acceptable salt of paroxetine selected from the group consisting of hydrohalides, sulfates phosphates, oxalate, tosylate, pamoate, citrate, carbonate, bicarbonate, maleate, malate, and fumarate.

6. The method of claim 1, wherein the dosage form comprises a pharmaceutically acceptable salt of paroxetine selected from the group consisting of hydrochloride, hydrobromide, and hydroiodide, and combinations of two or more thereof.

7. The method of claim 1, wherein the dosage form comprises a pharmaceuticall acceptable salt of paroxetine selected from the group consisting of sulfate and bisulfate, and combinations thereof.

8. The method of claim 1, wherein the dosage form comprises a pharmaceuticall acceptable salt of paroxetine selected from the group consisting of mono, di, and tri basic phosphates, and combinations of two or more thereof.

9. The method of claim 1, wherein the dosage form comprises paroxetine or a pharmaceutically acceptable salt thereof in anhydrate, hydrate, or solvate form, or combination of two or more thereof.

10. The method of claim 1, wherein the dosage form comprises paroxetine or a pharmaceutically acceptable salt thereof in a crystalline or amorphous form, or a combination thereof.

11. The method of claim 1, wherein the dosage form comprises paroxetine or a pharmaceutically acceptable salt thereof in a crystalline form.

12. The method of claim 1, wherein the dosage form comprises paroxetine or a pharmaceutically acceptable salt thereof in an amorphous form.