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(S)-Zopiclone Sepracor.

V Georgiev1

  • 1Institute of Physiology, Bulgarian Academy of Sciences, Sofia, Bulgaria. vasgeorg@yahoo.com

Current Opinion in Investigational Drugs (London, England : 2000)
|January 31, 2002
PubMed
Summary

(S)-Zopiclone, a sedative for sleeping disorders, has completed Phase II and initiated Phase III trials. Expected US filing in late 2001, with significant sales predicted by 2004.

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Area of Science:

  • Pharmacology
  • Central Nervous System (CNS) Therapeutics

Background:

  • Sepracor is developing (S)-Zopiclone, a cyclopyrrolone sedative.
  • (S)-Zopiclone exhibits activity similar to benzodiazepines in the CNS.
  • The drug is intended for the treatment of sleeping disorders.

Purpose of the Study:

  • To evaluate the efficacy and safety of (S)-Zopiclone for insomnia.
  • To advance (S)-Zopiclone through clinical trials for sleep disorders.

Main Methods:

  • Phase II clinical trials for (S)-Zopiclone in insomnia were completed by August 2000.
  • Phase III patient enrollment for insomnia studies was completed by September 2000.
  • Phase III trial initiation was planned for October 2000.

Main Results:

  • Merrill Lynch anticipates US filing for (S)-Zopiclone in the second half of 2001.
  • Predicted sales for (S)-Zopiclone were US $30 million in 2002, increasing to US $150 million by 2004.

Conclusions:

  • (S)-Zopiclone is progressing through late-stage clinical development for insomnia.
  • The drug shows commercial potential with significant sales forecasts.

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