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Related Experiment Videos

Lasofoxifene (Pfizer).

Luigi Gennari1

  • 1University of Siena, Department of Internal Medicine, Endocrine-Metabolic Sciences and Biochemistry, Policlinico Le Scotte, Siena, Italy. gennari@unisi.it

Current Opinion in Investigational Drugs (London, England : 2000)
|November 2, 2005
PubMed
Summary

Pfizer

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Area of Science:

  • Pharmacology
  • Endocrinology
  • Drug Development

Background:

  • Selective estrogen receptor modulators (SERMs) represent a class of compounds targeting estrogenic pathways.
  • Osteoporosis and vaginal atrophy are conditions influenced by estrogen levels.

Purpose of the Study:

  • To evaluate lasofoxifene, a novel SERM, for the treatment of osteoporosis and vaginal atrophy.
  • To assess the potential of lasofoxifene as an alternative therapeutic agent.

Main Methods:

  • Pfizer developed lasofoxifene, an oral naphthalene derivative SERM.
  • A New Drug Application was submitted to the FDA for osteoporosis treatment.

Main Results:

  • The FDA issued a non-approvable letter for lasofoxifene in September 2005.
  • The drug's development for osteoporosis faced regulatory challenges.

Conclusions:

  • Lasofoxifene's development for osteoporosis was halted by the FDA's decision.
  • Further research or alternative strategies may be needed for lasofoxifene's therapeutic application.