Healthcare Industry News: fluoxetine
News Release - June 23, 2006
Sepracor Announces Presentation of LUNESTA(TM) Data at Associated Professional Sleep Societies 20th Anniversary Meeting
MARLBOROUGH, Mass.--(HSMN NewsFeed)--June 23, 2006--Sepracor Inc. (Nasdaq: SEPR ) today announced that additional data on LUNESTA(TM) brand eszopiclone for the treatment of insomnia were presented at the SLEEP 2006 20th Anniversary Meeting of the Associated Professional Sleep Societies in Salt Lake City. The data included four oral presentations of results from LUNESTA Phase IIIB/IV study data.Efficacy and Safety of Six Months of Nightly Eszopiclone in Patients with Primary Insomnia: A Second Long-Term Placebo-Controlled Study
Results of a second six-month, double-blind, placebo-controlled study of LUNESTA 3 mg versus placebo in the long-term treatment of insomnia were presented. This 830-patient study evaluated various sleep measures, including sleep latency (time to sleep onset), wake time after sleep onset (WASO, a measure of sleep maintenance), total sleep time (TST) and sleep quality. Daytime function endpoints for patients administered LUNESTA versus patients administered placebo were also evaluated and included: daytime alertness, daytime functioning, ability to concentrate and think clearly, and sense of physical well-being. This study also included a two-week discontinuation phase in which all patients were administered placebo. The discontinuation phase allowed for assessment of withdrawal effects such as rebound and central nervous system (CNS) adverse events.
Sepracor is seeking publication of these study results, and in compliance with the specific journal requirements, has chosen to not disclose these results in this press release.
An Analysis of the Relationship Between Improvements in Sleep and Improvements in HAM-D17 Scores in Patients with New Onset Major Depressive Disorder (MDD) and Insomnia
A post-hoc analysis of the results of a 545-patient, double-blind study of LUNESTA in patients with insomnia and co-existing Major Depressive Disorder (MDD) was conducted to determine whether reductions in patients' HAM-D17 scores (Hamilton Depression Rating Scale; a list of symptoms associated with depression) during the study were attributable to improvements in sleep with co-therapy relative to monotherapy. The study was 8 weeks in duration during which time patients were administered either LUNESTA with fluoxetine or placebo with fluoxetine. There was also a two-week discontinuation phase during which time all patients were administered placebo with fluoxetine. Results of this analysis suggest that a moderate amount of the treatment effect of co-therapy on reductions in depression scores was explainable by co-therapy's effects on sleep measures at Week 4, and that the improvements in sleep from co-therapy explained more of the effect of co-therapy on reductions in depression scores at Week 4 than at Week 8.
The results of this post-hoc analysis do not establish safety or efficacy of LUNESTA as either a primary or adjunctive therapy for the treatment of depression. LUNESTA is indicated for the treatment of insomnia. LUNESTA is not indicated for the treatment of depression. Sedative hypnotics should be administered with caution to patients exhibiting signs and symptoms of depression.
Eszopiclone Treatment During Menopausal Transition: Sleep Effects, Impact on Menopausal Symptoms and Mood
A double-blind, placebo-controlled, four-week study of LUNESTA 3 mg versus placebo was performed in 410 women experiencing insomnia associated with menopausal transition. In the study, women reported statistically significant improvements in sleep onset (p<0.0001), sleep maintenance (reduced number of awakenings and WASO; p<0.0001), TST (p<0.0001), sleep depth (p<0.05) and sleep quality (p<0.0001), versus those women administered placebo. Improvements from baseline in measures of daytime function were also observed over the treatment period (p<0.05) for patients administered LUNESTA versus those administered placebo. Women who were treated with LUNESTA also experienced statistically significantly (p=0.001) fewer awakenings due to hot flushes than those women who were administered placebo during the study. The impact of treating insomnia on changes in mood, menopause-related symptoms and quality of life was evaluated by comparing baseline responses versus end-of-treatment responses for: physician global evaluations of menopause (PGE), a menopause-specific quality of life questionnaire (MenQOL), the Greene Climacteric Scale (GCS), the Montgomery Asberg Depression Rating Scale (MADRS) and the Sheehan Disability Scale (SDS). Patients treated with LUNESTA demonstrated statistically significantly greater improvements in MADRS total scores (p=0.02), total GCS (p=0.03) and PGEs (p<0.0001) versus patients administered placebo. Patients treated with LUNESTA reported statistically significant improvement in vasomotor (p=0.003) and physical (p=0.04) parameters of the MenQOL, but psychosocial and sexual responses were not significant versus placebo. Women administered LUNESTA also demonstrated statistically significant improvement in the family/home parameter of the SDS (p=0.04), but work/school and social life were not significant versus placebo.
The outcomes observed in this study on menopausal symptom scores are interpreted as resulting from the effects on sleep. LUNESTA is indicated for the treatment of insomnia. LUNESTA is not indicated for the treatment of menopausal symptoms.
Effect of Eszopiclone 3 mg Compared with Placebo in Patients with Rheumatoid Arthritis and Co-Existing Insomnia
Also presented at APSS were the results of a four-week, 153-patient, multi-center, double-blind trial assessing the safety and efficacy of LUNESTA versus placebo in patients with insomnia and co-existing rheumatoid arthritis (RA). In the study, all sleep endpoints were statistically significantly improved from baseline for patients administered LUNESTA versus patients administered placebo for each week of the study period, including: sleep latency (p<0.01), WASO (p<0.01), TST (p<0.05) and sleep quality (p< or =0.01). Patients treated with LUNESTA had mean Insomnia Severity Index (ISI) scores that were statistically significantly improved (p<0.001) versus patients administered placebo at Weeks 2 and 4. Overall scores for the Arthritis Self Efficacy Scale were statistically significant (p=0.046) in the LUNESTA treatment group versus patients administered placebo.
The outcomes observed in this study on RA symptom scores are interpreted as resulting from the effects on sleep. LUNESTA is indicated for the treatment of insomnia. LUNESTA is not indicated for the treatment of rheumatoid arthritis.
LUNESTA is indicated for the treatment of insomnia. LUNESTA is not indicated for the treatment of depression, rheumatoid arthritis or menopause. LUNESTA works quickly and should only be taken immediately before bedtime. Be sure you have at least eight hours to devote to sleep before becoming active. You should not engage in any activity after taking LUNESTA that requires complete alertness, such as driving a car or operating machinery. You should use extreme care when engaging in these activities the morning after taking LUNESTA. Do not use alcohol while taking any sleep medicine. Most sleep medicines carry some risk of dependency. Do not use sleep medicines for extended periods without first talking to your doctor. Please see your doctor if you experience unusual changes in thinking or behavior, or your sleep problems do not improve in 7 to 10 days as this may be due to another medical condition. Side effects may include unpleasant taste, headache, drowsiness and dizziness.
About Sepracor
Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor's drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.
Forward-Looking Statement
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy and potential benefits of LUNESTA brand eszopiclone. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: Sepracor's ability to fund, and the results of, further clinical trials; the timing and success of submission, acceptance, and approval of additional regulatory filings; the scope of Sepracor's patents and the patents of others; the commercial success of LUNESTA; any changes in the use and/or label of LUNESTA; the ability of the company to attract and retain qualified personnel; and certain other factors that are detailed in the company's quarterly report on Form 10-Q for the quarter ended March 31, 2006 filed with the Securities and Exchange Commission.
In addition, the statements in this press release represent Sepracor's expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor's expectations or beliefs as of any date subsequent to the date of this press release.
LUNESTA is a trademark of Sepracor Inc.
For a copy of this release or any recent release, visit Sepracor's web site at www.sepracor.com.
Source: Sepracor
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