-Multi-center trial demonstrates the potential for Aspect's brain assessment technology to predict response and remission one week following initiation of antidepressant treatment-NORWOOD, Mass., May 05, 2008 (BUSINESS WIRE) -- Aspect Medical Systems, Inc. (NASDAQ: ASPM) will present study
results from the BRITE (Biomarkers for Rapid Identification of
Treatment Effectiveness) trial in major depression at the Society of
Biological Psychiatry and American Psychiatric Association Annual
Meetings in Washington D.C. this week. BRITE trial results demonstrate
that Aspect's EEG-based Antidepressant Treatment Response (ATR)
indicator is a significant predictor of patient response and remission
when used after one week of treatment with the antidepressant
escitalopram. An economic analysis using the BRITE data to model the
potential health economic impact of ATR-guided treatment will also be
presented this week at the annual meeting of the International Society
for Pharmacoeconomics and Outcomes Research (ISPOR) in Toronto.
"We are pleased that the results of the BRITE trial indicate that
early changes in frontal EEG signals carry important information about
future clinical response, as this reinforces our confidence that an
EEG-based biomarker has the potential to help clinicians improve the
care of patients suffering from depression," said Andrew Leuchter,
M.D., professor of Psychiatry at the Semel Institute for Neuroscience
and Human Behavior at UCLA, principal investigator for the trial, and
chair of Aspect's Neuroscience Advisory Board.
The BRITE trial was conducted in collaboration with leading
investigators from 10 facilities across the United States and enrolled
375 patients. Patient response was defined by researchers as a 50
percent improvement in depression symptoms as measured by the Hamilton
Depression Rating Scale (HAM-D) after seven weeks of treatment, and
remission was defined as recovery from depression (HAM-D less than 7)
after seven weeks of treatment. In the BRITE study, ATR at one week
predicted response and remission with 74 percent accuracy in subjects
treated for seven weeks with escitalopram, which was statistically
significant. BRITE study results also suggest that Aspect's technology
may help clinicians expedite the process of identifying the most
effective type of antidepressant drug therapy for their patients
suffering from depression.
"We believe that having an early marker for response or remission
will help clinicians rapidly identify the most appropriate medication
for their patients and shorten the time needed to achieve successful
treatment. Our hope is that this could help eliminate the lengthy and
frustrating search for effective treatment, as well as potentially
encourage adherence to a treatment plan," said Dr. Leuchter.
Following completion of the BRITE trial, Aspect initiated work
with researchers at the Medical University of South Carolina (MUSC) to
model the potential economic benefits of the ATR biomarker for health
insurers and employers. Early findings from this effort indicate that
the use of ATR may provide a cost effective method for individualizing
care for patients with major depression. "By applying the BRITE data
to cost models of depression care, we demonstrated that the ATR
biomarker could be a cost effective measure that meets health economic
definitions of good value for new medical technologies," said Kit N.
Simpson, DrPH, Professor at the Center for Health Economic and Policy
Studies at MUSC. Abstracts highlighting these preliminary economic
analyses will be presented at the ISPOR meeting this week as well as
at the New Clinical Drug Evaluation Unit (NCDEU) conference in
Phoenix, AZ May 27-30.
In the United States alone, an estimated 15 million people
experience a depressive episode each year, and nearly 17 percent of
adults will experience major depression in their lifetime. The
majority of patients being treated for major depression are prescribed
a selective serotonin reuptake inhibitor (SSRI), such as escitalopram
(a commonly prescribed first-line antidepressant). Research has shown
that the majority of patients seeking treatment for depression will
not respond adequately to the first antidepressant treatment they are
prescribed, and in many cases, it can take months before a patient
responds to antidepressant medication and feels better. While
treatment with antidepressants will eventually lead to remission in
the majority of treated patients, many will require a second, third or
fourth treatment before experiencing relief.
Aspect plans to initiate a second confirmatory study named the
RAPID trial (Rapid Assessment for Prediction of Improvement in
Depression) seeking to prospectively validate the ATR biomarker as a
predictor of antidepressant treatment response. The trial is being
designed based on input from investigators as well as feedback from
the U.S. Food and Drug Administration and is expected to begin
mid-year 2008.
About Aspect Medical Systems, Inc.
Aspect Medical Systems, Inc. (NASDAQ: ASPM) is a global market
leader in brain monitoring technology. To date, the Company's
Bispectral Index (BIS) technology has been used to assess
approximately 26 million patients and has been the subject of more
than 3,300 published articles and abstracts. BIS technology is
installed in approximately 80 percent of hospitals listed in the July
2007 U.S News and World Report ranking of America's Best Hospitals and
in approximately 60 percent of all U.S. operating rooms. In the last
twelve months BIS technology was used in approximately 19 percent of
all U.S. surgical procedures requiring general anesthesia or deep
sedation. BIS technology is available in more than 160 countries.
Aspect Medical Systems has OEM agreements with nine leading
manufacturers of patient monitoring systems. The company is also
investigating how other methods of analyzing brain waves may aid in
the diagnosis and management of neurological diseases, including
depression and Alzheimer's disease. For more information, visit
Aspect's Web site at http://www.aspectmedical.com.
Safe Harbor Statement
Certain statements in this release are forward-looking and may
involve risks and uncertainties, including statements with respect to
the potential ability of the Company's brain assessment technology to
rapidly predict the effectiveness of antidepressant medications and
expedite the process of identifying effective antidepressant drug
therapy, the anticipated benefits of the BRITE trial, the Company's
anticipated timing with respect to initiating a confirmatory trial
mid-year 2008 as a final step toward preparing an FDA submission for
the technology and the Company's belief that it can develop a
practical, easy-to-use brain assessment device to help clinicians
optimize care for patients suffering from depression. There are a
number of factors that could cause actual results to differ materially
from those indicated by these forward-looking statements. For example,
the Company may not be able to successfully develop and/or obtain
required regulatory approvals for its products under development for
the diagnosis, management and treatment of neurological diseases, such
as depression and Alzheimer's disease, achieve widespread market
acceptance of any such products that it may develop or to compete with
new products or alternative techniques that may be developed by
others. In addition, the Company may not achieve comparable or
confirmatory results in later trials, including its planned RAPID
trial, as those achieved in earlier studies. There are other factors
that could cause the Company's actual results to vary from its
forward-looking statements, including without limitation those set
forth under the heading "Risk Factors" in the Company's Annual Report
on Form 10-K for the year ended December 31, 2007 as filed with the
Securities and Exchange Commission. In addition, any forward-looking
statements represent the Company's views only as of the date of this
press release and should not be relied upon as representing the
Company's views as of any subsequent date. While the Company may elect
to update forward-looking statements in the future, it specifically
disclaims any obligation to do so, even if its expectations change.
Therefore, you should not rely on these forward-looking statements as
representing the Company's views as of any date subsequent to the date
of this press release.
Aspect, Bispectral Index and BIS are registered trademarks of
Aspect Medical Systems, Inc. All other trademarks, service marks and
company names are the property of their respective owners.
SOURCE: Aspect Medical Systems, Inc.
Aspect Medical Systems
Emily Anderson, 617-559-7032
eanderson@aspectms.com
Media Relations