Source: Sepracor Inc.
Wednesday, May 21, 2003
Sepracor Inc. (Nasdaq: SEPR) today announced the presentation of Phase III
data for ESTORRA(TM) brand eszopiclone for the treatment of insomnia at the
American Psychiatric Association (APA) meeting in San Francisco.
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The U.S. Food and Drug Administration (FDA) accepted for filing Sepracor's
New Drug Application for ESTORRA brand eszopiclone on April 1, 2003.
The eszopiclone data presented at the APA meeting showcased the first
long-term (six-month), double-blind, placebo-controlled, efficacy and safety
study ever performed in patients with insomnia. This randomized, multi-center
study included chronic insomnia sufferers from 21-69 years of age. Patients
received nightly treatment of either placebo (n=195) or eszopiclone 3 mg
(n=593) for 6 months. In this study, subjective sleep maintenance, sleep
latency (onset of action), total sleep time and sleep quality were reported
weekly and safety was evaluated monthly.
The results were assessed monthly, with the eszopiclone arm showing
statistically significant improvements in sleep maintenance measures, (wake
time after sleep onset, number of awakenings and number of nights awakened),
sleep latency, total sleep time and sleep quality relative to placebo
(p<0.01). In this study, no decline in efficacy (i.e., no evidence of
tolerance) was observed over the course of the trial and eszopiclone was well
tolerated.
"Eszopiclone is a promising candidate for the treatment of insomnia and
the first compound to successfully complete a six-month, large-scale, double-
blind, placebo-controlled, efficacy and safety study in chronic insomnia
sufferers," said Andrew Krystal, M.D., Duke University Medical Center.
"Eszopiclone led to improvement in sleep maintenance without next-day
sedation, suggesting that there is potential to address the need for
treatments that safely help people stay asleep throughout the night. If
approved by the FDA, eszopiclone could provide physicians with an important
treatment option for insomnia patients."
"Chronic insomnia is a significant medical problem that we believe is
under-diagnosed and not optimally treated," stated Mark H.N. Corrigan, M.D.,
Executive Vice President, Research and Development at Sepracor. "We believe
the completion of our landmark long-term study provides data on a compound
that, if approved by the FDA, could represent a true advance in the treatment
of chronic insomnia sufferers."
According to the National Sleep Foundation, insomnia affects approximately
50 million people in the U.S. Insomnia symptoms may include difficulty
falling asleep, awakening frequently during the night, awakening too early in
the morning, or awakening feeling unrefreshed. Causes of insomnia can include
illness, changes in environmental temperatures or surroundings, jet lag,
medication side effects, stress or anxiety. The U.S. market for prescription
sleep products was approximately $1.4 billion in 2002, and grew at a rate of
almost 25 percent for the past two years, according to IMS Health information.
Chronic insomnia is often associated with underlying medical or
psychiatric disorders. According to Market Measures Interactive, chronic
insomnia can be characterized as lasting 3 weeks or longer, but can also be
described as shorter periods of insomnia that recur frequently over extended
periods of time, such as months or years. Approximately 45% of insomniacs
suffer from chronic insomnia, many of whom are elderly.
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,
including candidates for the treatment of respiratory, urology and central
nervous system disorders. 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,
potential benefits and successful development and regulatory approval of
ESTORRA brand eszopiclone and Sepracor's other pharmaceuticals under
development. Among the factors that could cause actual results to differ
materially from those indicated by such forward-looking statements are: the
results of clinical trials with respect to products under development; the
timing and success of submission, acceptance and approval of regulatory
filings; the scope of Sepracor's patents and the patents of others; the
commercial success of Sepracor's products; the ability of the company to
attract and retain qualified personnel; the performance of Sepracor's
licensees; the availability of sufficient funds to continue research and
development efforts; the continued ability of Sepracor to meet its debt
obligations when due; and certain other factors that may affect future
operating results and are detailed in Sepracor's quarterly report on Form 10-Q
for the quarter ended March 31, 2003 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.
Estorra is a trademark of Sepracor Inc.
To receive a copy of this release or any recent release via fax,
Sepracor's automated news fax line at 1-800-758-5804 ext. 780960
call or visit the web site at http://www.sepracor.com.
Contacts:
David P. Southwell
Chief Financial Officer
Sepracor Inc.