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Pregabalin (Pfizer).

Richard Huckle1

  • 1Axovan Ltd., Innovation Center, Gewerbestrasse 16, CH-4123 Allschwil, Switzerland. richard.huckle@axovan.com

Current Opinion in Investigational Drugs (London, England : 2000)
|February 27, 2004
PubMed
Summary

Pregabalin, a gamma-aminobutyric acid analog, is being developed for central nervous system disorders. Regulatory submissions were filed for epilepsy, neuropathic pain, and generalized anxiety disorder, with fibromyalgia trials ongoing.

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Area of Science:

  • Neuroscience
  • Pharmacology

Background:

  • Pregabalin is a gamma-aminobutyric acid (GABA) analog.
  • It is under development for central nervous system (CNS) disorders.

Purpose of the Study:

  • To evaluate pregabalin for epilepsy, neuropathic pain, fibromyalgia, and generalized anxiety disorder.
  • To seek regulatory approval for these indications.

Main Methods:

  • Filing for regulatory approval in Europe and submitting an NDA in the US.
  • Conducting ongoing Phase III clinical trials for fibromyalgia.

Main Results:

  • Regulatory submissions filed for neuropathic pain, epilepsy, and generalized anxiety disorder.
  • Phase III trials for fibromyalgia were in progress.

Conclusions:

  • Pregabalin demonstrated potential for treating various CNS disorders.
  • Regulatory review was underway for key indications.