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Published on 5/25/2006 in the Prospect News Biotech Daily.

Sepracor: Lunesta sleep benefits minimize rheumatoid arthritis, menopause symptoms

By Elaine Rigoli

Tampa, Fla., May 25 - Sepracor Inc. said data from its phase 3b/4 studies of Lunesta brand eszopiclone for the treatment of insomnia also showed benefits for patients suffering from rheumatoid arthritis and menopause.

In this phase 3b/4, 153-patient, four-week, randomized, double-blind, placebo-controlled pilot study, nightly use of Lunesta 3 mg resulted in statistically significant improvement from baseline compared with a placebo in patient-reported measures of sleep latency, wake-time after sleep onset, total sleep time and sleep quality for each week of the four-week study.

Sepracor said for those with rheumatoid arthritis, patients administered Lunesta reported improvement in the arthritis self-efficacy scale, in the American College of Rheumatology rheumatoid arthritis joint assessment and in two items of the SF-36 acute health survey at week four versus those patients administered a placebo.

Sepracor said the outcomes observed in this study on rheumatoid arthritis symptom scores are interpreted as resulting from the effects on sleep.

Sepracor also said it studied the sleep effects of Lunesta and related impact on menopausal symptoms and mood.

The trial, a six-week, 410-patient, randomized, double-blind, placebo-controlled study, suggested that nightly use of Lunesta 3 mg resulted in statistically significant improvement from baseline compared with a placebo in patient-reported measures of sleep latency, wake time after sleep onset and total sleep time for each week of the four-week, double-blind treatment period.

Compared to baseline and averaged over the double-blind period, women treated with Lunesta reported fewer total nocturnal awakenings and fewer awakenings due to hot flashes compared to those patients administered a placebo.

Sepracor said the outcomes observed in this study on menopausal symptom scores are interpreted as resulting from the effects on sleep.

Based in Marlborough, Mass., Sepracor is a research-based pharmaceutical company.


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