Methods and compositions for treating or preventing symptoms of hormonal variations
Inventors
Assignees
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Publication Number
US-9457022-B2
Publication Date
2016-10-04
Expiration Date
Abstract
The present invention relates to methods, compositions, and kits for treating or preventing symptoms of hormonal variation. The method comprises the steps of administering an effective amount of Dextromethorphan or Dextrorphan, or a pharmaceutically acceptable salt thereof, to a subject having one or more symptoms of hormonal variations.
Core Innovation
The invention relates to a method for treatment of symptoms of hormonal variation. The method includes identifying a subject having one or more symptoms of hormonal variations resulting in hot flashes and night sweats, and administering an effective amount of Dextromethorphan or Dextrorphan, or a pharmaceutically acceptable salt thereof, as the only active agents administered.
The disclosed treatment is directed to subjects experiencing hormonal variation symptoms, including hot flashes, night sweats, and insomnia, and associates the symptoms with menopause and perimenopause. The disclosure also associates hormonal variation with partial hysterectomy, anti-estrogen drugs such as tamoxifen and aromatase inhibitors, and androgen deprivation therapy (ADT) such as prostate cancer treatments including Zoladex (goserelin) and Lupron (leuprolide).
The document proposes a mechanism involving modulation of dopamine, norepinephrine, and serotonin, including NMDA receptor binding and transporter effects. It further includes discussion of receptors including 5-HT2A receptor and D2 receptor, and describes controlled/extended-release formulations, transdermal patch formats, and kit formats.
Claims Coverage
The independent claim covers treatment of hot flashes and night sweats associated with hormonal variations using dextromethorphan or dextrorphan as the only active agents administered. The dependent claims further refine the method by specifying dextromethorphan hydrobromide, a quantitative daily dosage range, and limiting the subject to female or male.
Only-active-agent treatment of hormonal variation symptoms
A method for treatment of symptoms of hormonal variation, comprising identifying a subject having one or more symptoms of hormonal variations resulting in hot flashes and night sweats; and administering an effective amount of Dextromethorphan or Dextrorphan, or a pharmaceutically acceptable salt thereof, wherein the Dextromethorphan or Dextrorphan are the only active agents administered.
Dextromethorphan hydrobromide embodiment
The method wherein the dextromethorphan is dextromethorphan HBr.
Quantified daily dosage range for active agent
The method uses an effective amount of Dextromethorphan or Dextrorphan of 0.1 to 120 mg per day.
Female subject limitation
The method is carried out with a female subject.
Male subject limitation
The method is carried out where the subject is male.
Across the claim set, the core inventive concept is treating hot flashes and night sweats from hormonal variations by administering an effective amount of dextromethorphan or dextrorphan as the only active agent. Dependent claims define salt form, quantify a daily dosage range, and specify the treated subject as female or male.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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