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Norastemizole Sepracor.

K A Bachmann1

  • 1University of Toledo, College of Pharmacy, 2801 W Bancroft Street, Toledo, OH 43606, USA. kbachma@utnet.utoledo.edu

Current Opinion in Investigational Drugs (London, England : 2000)
|March 16, 2001
PubMed
Summary

Norastemizole, a potent non-sedating histamine H1 antagonist, shows rapid allergy relief with no cardiotoxicity. This active metabolite of Hismanal is expected to file for FDA approval soon.

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Area of Science:

  • Pharmacology
  • Allergology

Background:

  • Norastemizole is a novel histamine H1 antagonist developed for non-sedating allergy treatment.
  • It is an active metabolite of astemizole (Hismanal).

Purpose of the Study:

  • To evaluate the efficacy and safety of norastemizole for allergic rhinitis.
  • To position norastemizole as a potent, non-sedating allergy therapeutic with a rapid onset of action.

Main Methods:

  • Phase III clinical trials for seasonal allergic rhinitis.
  • Assessment of histamine-induced wheal and flare responses post-administration.
  • Evaluation of cardiotoxicity and drug interaction profiles.

Main Results:

  • Norastemizole demonstrates 13- to 16-fold greater H1 antagonist potency than astemizole.
  • Significant reduction in histamine-induced wheal and flare responses within 30 minutes of a 25 mg oral dose.
  • Lack of observed cardiotoxicity or drug interactions that increase arrhythmia risk.

Conclusions:

  • Norastemizole is a highly potent, non-sedating H1 antagonist with rapid onset of action.
  • Its favorable safety profile, particularly the absence of cardiotoxicity, distinguishes it from other allergy treatments.
  • Anticipated FDA approval and strong market potential for allergic rhinitis treatment.

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