US2014378499A1PendingUtilityA1

Methods and compositions for treating or preventing symptoms of hormonal variations

Assignee: FERVENT PHARMACEUTICALS LLCPriority: Mar 2, 2010Filed: Sep 11, 2014Published: Dec 25, 2014
Est. expiryMar 2, 2030(~3.6 yrs left)· nominal 20-yr term from priority
A61K 31/197A61P 5/30A61K 31/485A61K 31/195A61P 5/00A61K 31/439A61K 45/06A61K 31/4748
47
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Claims

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.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for treatment or prevention of symptoms of hormonal variation, comprising:
 identifying a subject having one or more symptoms of hormonal variations; and   administering an effective amount of Dextromethorphan or Dextrorphan, or a pharmaceutically acceptable salt thereof, to the subject.   
     
     
         2 . The method of  claim 1  wherein said Dextromethorphan is DextromethorphanHBr. 
     
     
         3 . The method of  claim 1  wherein said symptoms of hormonal variation comprise hot flashes and night sweats. 
     
     
         4 . The method of  claim 1  wherein the effective amount of Dextromethorphan or Dextrorphan is from 0.1 to 120 mg per day. 
     
     
         5 . The method of  claim 1  wherein the subject is a female. 
     
     
         6 . The method of  claim 1  wherein the subject is a male. 
     
     
         7 . The method of  claim 1  further comprising administering an effective amount of Dextromethorphan or Dextrorphan, or a pharmaceutically acceptable salt thereof, in a controlled-release or a sustained-release dosage form. 
     
     
         8 . The method of  claim 1  further comprising administering an effective amount of Dextromethorphan or Dextrorphan, or a pharmaceutically acceptable salt thereof, through a transdermal patch. 
     
     
         9 . A method for treatment or prevention of symptoms of hormonal variation, comprising:
 identifying a subject having one or more symptoms of hormonal variations; and   administering an effective amount of Dextromethorphan or Dextrorphan, or a pharmaceutically acceptable salt thereof, and another compound known to reduce or prevent the symptoms of hormonal variation to the subject.   
     
     
         10 . The method of  claim 9 , wherein the another compound known to reduce or prevent the symptoms of hormonal variation is selected from the group consisting of a conjugated estrogen, bupropian, venlafaxine, fluoxetine, duloxetine, sertraline, clonidine, clonidine hydrochloride, methyldopa, and gabapentin. 
     
     
         11 . The method of  claim 10  wherein said another compound is gabapentin. 
     
     
         12 . The method of  claim 11  wherein the amount of Dextromethorphan or Dextrorphan administered is from 0.1 to 120 mg per day and the amount of gabapentin administered is from 1 mg to 900 mg per day. 
     
     
         13 . The method of  claim 1  further comprising administering an effective amount of Dextromethorphan or Dextrorphan, or a pharmaceutically acceptable salt thereof, and another compound known to reduce or prevent the symptoms of hormonal variation in a controlled-release or sustained-release dosage form. 
     
     
         14 . The method of  claim 1  further comprising administering an effective amount of Dextromethorphan or Dextrorphan, or a pharmaceutically acceptable salt thereof, and another compound known to reduce or prevent the symptoms of hormonal variation through a transdermal patch. 
     
     
         15 . A pharmaceutical composition for treatment or prevention of symptoms of hormonal variation, comprising:
 an effective amount of Dextromethorphan or Dextrorphan, or a pharmaceutically acceptable salt thereof, in a pharmaceutically acceptable carrier; and   wherein the Dextromethorphan or Dextrorphan, or pharmaceutically acceptable salt thereof, is used to treat or prevent symptoms of hormonal variation.   
     
     
         16 . A kit for treatment or prevention of symptoms of hormonal variation, comprising:
 an effective amount of Dextromethorphan or Dextrorphan, or a pharmaceutically acceptable salt thereof, in a pharmaceutically acceptable carrier; and   instructions for performing at least one method of the invention.   
     
     
         17 . The kit of  claim 16 , wherein said Dextromethorphan is DextromethorphanHBr. 
     
     
         18 . The kit of  claim 16 , further comprising a pharmaceutically acceptable form of Dextromethorphan or Dextrorphan in at least one of oral dosage form, injection, inhalation, and transdermal patch. 
     
     
         19 . The kit of  claim 18 , wherein said oral dosage form comprises a solution, gel, tablet, capsule, or powder. 
     
     
         20 . The kit of  claim 18 , wherein said oral dosage form comprises a controlled-release dosage form, a rapidly dispersed dosage form with a porous network of a matrix composition, or a solid rapidly disintegrating dosage form.

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