Sepracor begins patient enrollment for Phase III study of insomnia drug

Sepracor Inc. (Marlborough, MA) has initiated patient enrollment in its Phase III trial of (S)-zopiclone for the treatment of insomnia. (S)-Zopiclone is a single-isomer version of racemic zopiclone, a non-benzodiazepine, rapid-acting hypnotic prescribed worldwide for the treatment of insomnia.

The company also plans to launch a second, parallel Phase III clinical study of (S)-zopiclone in October. Combined patient enrollment in the two studies is expected to reach approximately 300.

Rhone Poulenc-Rorer currently markets racemic zopiclone in some 80 countries under the brand names of Imovane and Amoban. However, the company never submitted the drug for approval in the United States. In 1999, racemic zopiclone was the leading treatment for sleep disorders outside the United States.

Sepracor is a specialty pharmaceutical company that develops and commercializes Improved Chemical Entities (ICE)—potentially improved versions of widely prescribed drugs. ICE Pharmaceuticals are designed to offer improvements in patient outcome through reduced side effects, increased therapeutic efficacy, improved dosage forms, and in some cases, the opportunity for additional indications.

For more information: Sepracor Inc., 111 Locke Dr., Marlborough, MA 01752. Tel: 508-481-6700. Fax: 508-357-7499.

Edited by Jim Pomager
Assistant Editor, Pharmaceutical Online