LUNESTA Phase III/IV Data Presented at 2005 Associated Professional Sleep Societies Meeting Poster Sessions
Sepracor Inc. (Nasdaq: SEPR) announces that it will be presenting LUNESTA(TM) brand eszopiclone posters today at the 19th Annual Meeting of the Associated Professional Sleep Societies (APSS) at the Colorado Convention Center in Denver. Two additional posters were presented earlier in the week.
A Dose-Response Efficacy and Safety Study of Eszopiclone in the Treatment of Primary Insomnia; Wednesday, June 22, 2005, 1:30 – 3:00 p.m., Lower Level Rooms 1/2/3
Results of a multicenter, double-blind, placebo-controlled, 65-patient, six-way crossover study in which patients were randomly administered eszopiclone (LUNESTA) 1 mg, 2 mg, 2.5 mg and 3 mg; zolpidem (AMBIEN(R)) 10 mg; or placebo, will be presented. AMBIEN was included as an active control in this study.
Patients were administered either eszopiclone, zolpidem or placebo for two nights in a sleep lab, followed by a three to seven day washout period. In this study, results were measured objectively in a sleep lab by polysomnography (PSG; a diagnostic test in which a number of physiologic variables are measured and recorded during sleep) and showed that all active treatments reduced latency to persistent sleep (p < or = 0.0001) and increased sleep efficiency (p < or = 0.05). Only eszopiclone 3 mg significantly improved sleep maintenance endpoints (p < or = 0.05), which included reductions in wake time after sleep onset (WASO; a sleep maintenance measurement of the amount of time spent awake after initially falling asleep), wake time during sleep and number of awakenings, versus placebo. Among patient-reported measures, morning sleepiness was improved with eszopiclone 2.5 mg and 3 mg versus placebo (p < or = 0.05), but not with any of the other treatment arms. All active treatment groups, except for eszopiclone 1 mg, demonstrated improved sleep quality and depth of sleep relative to placebo (p < 0.05). Adverse events reported in more than 4% of patients following treatment with eszopiclone 3 mg or zolpidem 10 mg were dizziness (eszopiclone: 4.7%, zolpidem: 10.9%, placebo: 4.8%), somnolence (eszopiclone: 4.7%, zolpidem: 9.4%, placebo: 3.2%); headache (eszopiclone: 9.4%, zolpidem: 9.4%, placebo: 9.5%); unpleasant taste (eszopiclone: 7.8%, zolpidem: 0%, placebo: 1.6%) and hallucinations (eszopiclone: 0%, zolpidem: 4.7%, placebo: 0%).
Analysis of the Treatment Effect of Eszopiclone on Sleep Parameters That Affect Next-Day Function in the Elderly; Wednesday, June 22, 2005, 1:30 – 3:00 p.m., Lower Level Rooms 1/2/3
An analysis was performed on the results of a study in older adult patients to determine the correlation between nighttime sleep and next-day function, as well as to investigate the percent of the treatment effect on changes in next-day function that is attributable to the effect of eszopiclone on changes in particular sleep parameters. The analysis was based on data from a randomized, double-blind, placebo-controlled, parallel-group study in patients 65 to 85 years of age with primary insomnia who received eszopiclone 2 mg (n=79) or placebo (n=80) for two weeks. The analysis showed that a mild to moderate correlation existed between patient-reported next-day function and patient-reported sleep parameters such as sleep quality, sleep depth, total sleep time (TST), WASO, sleep latency (time to sleep onset) and number of awakenings. Improvements in next-day function were most strongly related (percent of treatment effect) to eszopiclone-mediated improvements in sleep quality, depth and maintenance.
Evaluation of the Safety and Efficacy of Eszopiclone in Patients With Obstructive Sleep Apnea; Presented Tuesday, June 21, 2005
The results of a randomized, double-blind crossover study evaluating the safety and efficacy of eszopiclone 3 mg in 21 patients with mild-to-moderate obstructive sleep apnea (OSA; a temporary cessation of breathing during sleep) were presented yesterday. Hypnotics are sometimes prescribed to patients with OSA to assist with transition to therapy with continuous positive airway pressure (CPAP). However, there is concern in the medical community about the potential for this class of drugs to worsen apnea, and limited research has been conducted to date. To evaluate the effect of eszopiclone on OSA, the following endpoints were measured: total apnea-hypopnea index (AHI; a measure of the number of combined apnea and hypopnea episodes per hour); apnea episodes per hour; hypopnea (breathing that is shallower and/or slower than normal) episodes per hour; total arousals per hour; respiratory arousals per hour; duration of apnea and hypopnea episodes; and oxygen saturation during apnea and hypopnea episodes. For all of these endpoints, the results showed no significant differences between eszopiclone and placebo. With respect to the effect of eszopiclone on sleep, eszopiclone significantly decreased spontaneous arousals per hour (p=0.02), improved wake time during sleep (p=0.013) and WASO (p=0.01), and improved sleep efficiency (p=0.01), versus placebo. Reductions in latency to persistent sleep and number of awakenings were not statistically significant versus placebo. Eszopiclone was well tolerated in this study.
Using Medical Claims Data and Clinical Literature to Forecast the Impact of Adding a New Drug Onto the Formulary: A Case Study of Insomnia Treatment; Presented Monday, June 20, 2005
Medical claims data from a database of more than 86,000 insomnia patients, and clinical trial data, were combined to develop a budget impact model to evaluate the potential cost savings of adding a new drug to a health plan’s formulary. In this case, eszopiclone was evaluated.
Using a multi-step process, insomnia drug efficacy was estimated globally from available literature on marketed drugs and from clinical trial reports of eszopiclone. Adjustments for the different characteristics of each clinical trial (size, location, patient characteristics, etc.) were made prior to summarizing the trial data. A multiple regression model was then applied to the claims database and to the clinical trial efficacy data in order to estimate a relationship between medical expenditures and treatment efficacy. Total costs for eszopiclone were assessed based on the drug’s efficacy as measured by patient-reported and PSG-assessed objective measures. The regression model also accounted for the impact of other demographics and clinical characteristics that influence expenditures. This analysis showed that, for a hypothetical representative health plan with 100,000 enrollees, use of eszopiclone would decrease annual insomnia treatment costs by $587,881 when using TST as the primary efficacy measure. Findings were similar using other efficacy endpoints.
About LUNESTA
LUNESTA is a new non-benzodiazepine indicated for the treatment of insomnia in patients who experience difficulty falling asleep as well as for the treatment of patients who have difficulty sleeping through the night (sleep maintenance difficulty). LUNESTA is approved for long-term use. LUNESTA 1 mg, 2 mg and 3 mg tablets are available by prescription in pharmacies nationwide.
An estimated 100 million adult Americans suffer from either chronic or occasional insomnia.(1) Symptoms of insomnia include difficulty falling asleep, awakening frequently during the night, waking up too early, an inability to fall back to sleep or awakening feeling unrefreshed.
Important Safety Information
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. All sleep medicines carry some risk of dependency. Do not use sleep medicines for extended periods without first talking to your doctor. Side effects may include unpleasant taste, headache, drowsiness and dizziness.
Please visit http://www.sepracor.com or http://www.lunesta.com to access the FDA-approved labeling text for LUNESTA.
About Sepracor
Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease through the discovery, development and commercialization of innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor’s drug development program has yielded an extensive portfolio of pharmaceutical compound candidates with a focus on respiratory and central nervous system disorders. The company’s commercialization efforts are carried out by its U.S.-based, 1,250-person, primary care and specialty-oriented sales force. Sepracor’s corporate headquarters are located in Marlborough, Massachusetts.
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. 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; changes in the uses and/or labeling of LUNESTA; concerns of LUNESTA prescribers or patients; the accuracy of the assumptions used in, and the result of, the budget impact model; and certain other factors that are detailed in the company’s quarterly report on Form 10-Q for the quarter ended March 31, 2005 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. Ambien is a registered trademark of sanofi-aventis Corporation.
(1) Extrapolated to current population from 2000 census based on Ancoli-Israel et al. SLEEP. 1999;22 (suppl 2):S347-S353
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