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Combinations of eszopiclone and O-desmethylvenlafaxine, and methods of treatment of menopause and mood, anxiety, and cognitive disorders

A technology for eszopiclone and mood disorders, applied in the composition of anxiety disorders and cognitive disorders, in the field of treatment of menopause and mood disorders, and can solve problems such as inability to improve cognitive function

Inactive Publication Date: 2008-09-03
SEPACOR INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, some experts believe that removing hematomas does little to improve cognitive function after they have put pressure on the brain for a long time (perhaps a year or more)

Method used

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  • Combinations of eszopiclone and O-desmethylvenlafaxine, and methods of treatment of menopause and mood, anxiety, and cognitive disorders
  • Combinations of eszopiclone and O-desmethylvenlafaxine, and methods of treatment of menopause and mood, anxiety, and cognitive disorders
  • Combinations of eszopiclone and O-desmethylvenlafaxine, and methods of treatment of menopause and mood, anxiety, and cognitive disorders

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0114] Example 1. Dosage Form

[0115] The following dosage form is an example of a combination tablet or capsule of eszopiclone and O-desmethylvenlafaxine:

[0116] Table 1. Combination dosage forms of eszopiclone and (-)-O-DMV

[0117]

[0118] Table 2. Combination Dosage Forms of Eszopiclone and Racemic O-DMV

[0119]

[0120]

[0121] * 1.0 mg O-DMV free base is equivalent to 1.517 mg succinate monohydrate salt.

[0122] Above-mentioned dosage form can carry out following steps to prepare:

[0123] 1. Screening eszopiclone by 80 mesh.

[0124] 2. Screen O-DMV through 40 mesh.

[0125] 3. Sift remaining ingredients through #20 or #30 mesh sieve.

[0126] 4. Mix eszopiclone and part of MCC (microcrystalline cellulose).

[0127] 5. Mix O-DMV with the mixture from step 4.

[0128] 6. Mix the mixture from step 5 with the remaining MCC from step 3.

[0129] 7. Mix the mixture from step 6 with the dicalcium phosphate.

[0130] 8. Mix the croscarmellose with the s...

Embodiment 2

[0135] Example 2. Clinical research on the treatment of menopause or perimenopause with eszopiclone

[0136] The aim of the study was to observe the efficacy of eszopiclone 3 mg compared with placebo in the treatment of insomnia secondary to perimenopause or menopause.

[0137] The study was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. The study had a one-week single-blind placebo enrollment period, followed by four weeks of double-blind treatment and a one-week single-blind placebo wash-out. The preliminary method of analysis compared post-randomization results between the two treatment groups.

[0138] The subjects were women with insomnia secondary to perimenopause or menopause. Subjects are pre-menopausal or menopausal and suffer from insomnia symptoms, including sleep latency (SL) ≥ 45 minutes and total sleep time (TST) ≤ 6 hours. Perimenopausal / menopausal symptoms precede sleep disturbance symptoms. The patient population was pre...

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PUM

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Abstract

One aspect of the present invention relates to pharmaceutical compositions containing two or more active agents that when taken together can be used to treat, e.g., menopause, mood disorders, anxiety disorders, or cognitive disorders. The first component of the pharmaceutical composition is a sedative eszopiclone. The second component of the pharmaceutical composition is O-desmethylvenlafaxine. The present invention also relates to a method of treating menopause, perimenopause, mood disorders, anxiety disorders, and cognitive disorders.

Description

field of invention [0001] The present invention relates to compositions and methods for treating menopause and mood disorders, anxiety disorders and cognitive disorders. Background of the invention [0002] Menopause, caused by decreased production of female sex hormones, typically occurs around age 50 but can occur at much earlier or later ages and can produce disturbances such as edema, hot flashes (or flushes), Sweating, muscle pain and possibly joint pain, sleep disturbance, restlessness, nervousness, mood swings, headache, palpitations (increased heart rate frequency), dry mucous membranes, pain during intercourse, and urinary disturbance. Hot flashes, or flushes, are characterized by sudden warmth in the face and neck, often spreading to the chest. Attacks usually last a few minutes and are manifested by visible flushing of the skin. Often such episodes are accompanied by diaphoresis, dizziness, nausea, palpitations, and sweating. Such symptoms can disrupt sleep and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/135A61K31/495
CPCA61K31/137A61K31/4985A61P15/08A61P25/14A61P25/16A61P25/18A61P25/20A61P25/22A61P25/24A61P25/28A61P43/00A61K2300/00
Inventor J·卡伦T·韦塞尔K·拉尔吉M·A·瓦尼
Owner SEPACOR INC
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