Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Pregabalin (Pfizer).

I Selak1

  • 1CNS Therapeutic Group, UCB Pharmaceuticals, Braine-L'Alleud, Belgium. ivan.selak@ucb-group.com

Current Opinion in Investigational Drugs (London, England : 2000)
|September 27, 2001
PubMed
Summary
This summary is machine-generated.

Pfizer

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Significance of immunohematologic testing in mother and newborn ABO incompatibility.

Immunohematology·2023
Same author

Demonstration of perycriptal fibroblasts in inflammatory-regenerative and dysplastic epithelial lesions of the flat colonic mucosa.

Advances in clinical pathology : the official journal of Adriatic Society of Pathology·2007
Same author

The anti-epileptic drug levetiracetam reverses the inhibition by negative allosteric modulators of neuronal GABA- and glycine-gated currents.

British journal of pharmacology·2002
Same author

Carcinoembryonic antigen (CEA) in colonic inflammatory-regenerative and dysplastic epithelial lesions.

Croatian medical journal·1998
Same author

[Multiple neoplasms].

Medicinski arhiv·1995
Same author

[Diagnostic and prognostic contribution of somatosensory evoked potentials by truncular and dermatomal stimulation in lumbosacral radiculopathy. Apropos of 120 cases surgically-treated].

Revue neurologique·1994

Area of Science:

  • Neuroscience
  • Pharmacology

Background:

  • Pregabalin, a novel central nervous system (CNS) disorder therapeutic, is under development by Pfizer.
  • It is a follow-up compound to gabapentin, a GABA agonist.

Purpose of the Study:

  • To investigate the potential of pregabalin for treating epilepsy, neuropathic pain, anxiety, and social phobia.
  • To outline the anticipated regulatory filing timeline with the FDA and approval in Japan.

Main Methods:

  • Regulatory filings with the FDA for multiple indications including neuropathic pain, epilepsy, generalized anxiety disorder, social anxiety disorder, fibromyalgia, and panic disorders.
  • Phase II clinical development in Japan for neuropathic pain.

Main Results:

  • Anticipated FDA NDA filings by end of 2001 for neuropathic pain and add-on epilepsy, with further filings in 2002 and 2003 for other indications.

Related Experiment Videos

  • Anticipated 2005 approval in Japan for neuropathic pain.
  • February 2001: Pfizer restricted pregabalin use in some patients and halted neuropathic pain trials due to FDA concerns over a mouse study indicating tumor incidence.

    • Conclusions:

    • Pregabalin development faced setbacks due to safety concerns identified in preclinical studies.
    • Despite potential efficacy in CNS disorders, regulatory hurdles and safety findings impacted its development trajectory and market projections.