Not only do atypical antipsychotics differ in their ability to improve
cognition, they have
different side effect profiles. The survey shows
that more than 75 percent of patients on antipsychotic
medications gain
weight and of those who said they gained weight, the average weight gain is
52
pounds. is the independent publisher of the monthly
journals Primary Psychiatry and CNS Spectrums
, as well as a host of
enduring material programs in conjunction with Mount Sinai School of
Medicine
.
Cummins.com/depression/hcp/ReimbursementIns/casebycase. We continue to work diligently
with
all third party payers to provide them with all the information they need
to follow our lead and
give Americans with health insurance suffering from TRD
the same universal access to VNS Therapy
that Americans with epilepsy have had
for over five years and that Cyberonics is now providing to
TRD study patients
and indigent Americans with no insurance.
"Official closure of the TRD
IDE confirms that VNS Therapy for its
approved indication for use, is neither experimental nor investigational
,"
concluded Mr. The Company is headquartered in Houston, Texas
and has an office in Brussels
, Belgium.depression recognizable
The survey found that virtually everyone with
schizophrenia (94%) believes that daily
functioning is part of successful
treatment for schizophrenia and most (83%) believe with the right
medications, people with schizophrenia should be able to lead full lives. The VNS Therapy System
is also approved for sale as a treatment
for epilepsy in all the European Economic Area, Canada,
Australia and other
markets." As part of FDA's approval order, Cyberonics is
required to conduct
a 450- patient post-market dosing study and a 1,000-
patient, five-year patient outcome registry
.Depression is a disturbance in mood characterized by varying degrees of sadness, disappointment, loneliness
, hopelessness, self-doubt, and guilt.
treatable depressionet
No additional depression studies under an Investigational Device
Exemption are currently underway or being planned by Cyberonics.cyberonics.
SAFE HARBOR
STATEMENT
This press release contains forward-looking statements within the meaning
of Section
27A of the Securities Act of 1933, as amended and Section 21E of
the Securities Exchange Act of 1934
, as amended.treatable measurable
"
While medications to treat schizophrenia's positive symptoms (such as
hallucinations
, delusions, and disorganization) have existed since the
mid-20th century, newer medications introduced
in the early 1990s, known as
atypical antipsychotics, also control the often overlooked symptoms
of
depression, suicidal thoughts, and problems remembering or concentrating
(affective and cognitive
symptoms). In addition, interest
and motivation are diminished and many individuals become depressed
and
socially withdrawn. If you would like to learn more about MBL Communications,
Inc.recognizable measurable
-- Among those taking antipsychotics, most (74%) also feel their current
medication falls short
in controlling depression while 49% of all
respondents said their doctors place "a great deal
" of importance on
depression when making treatment decisions.
Schizophrenia is associated
with changes in cognition that affect the
ability to remember and to plan for achieving goals.vnstherapy
. Statements contained in this press
release are based upon information presently available to us
and assumptions
that we believe to be reasonable.depressive fluctuations
PRESS RELEASE Common Schizophrenia Symptoms Often
Overlooked by Physicians According to Expert Panel
Weiden, Schooler and Harvey, Peter F. The cause
of schizophrenia is
unknown, but it is believed to be the result of abnormal brain functioning.
Lastly, Cyberonics also
announced a $15 million TRD Indigent Access Program, similar to its B. Cyberonics
will provide up to 200 VNS Therapy
Systems per year over a five year period in this program to qualified
patients
through experienced hospitals and trained psychiatrists. "Although over 85 different
third
party payers, including 19 different Blue Cross/Blue Shield plans,
United Healthcare, CIGNA, Aetna
, Humana and several regional Medicare carriers
have to date granted at least one American with TRD
access to VNS Therapy
(http://www.com or call
1-877-NOW 4 VNS.debunked recognizable
We are not assuming any duty to
update this
information should those facts change or should we no longer believe the
assumptions
to be reasonable.debunked affective
The supplement, entitled Optimizing Treatment of Schizophrenia: Enhancing
Affective
/Cognitive and Depressive Functioning, includes a discussion of
the results of a new Harris Interactive
national consumer survey of
people with schizophrenia, which clearly illustrates the problem:
-- 65% reported that, when making treatment decisions, their doctors
place "a great deal
" of importance on positive symptoms while only 37% felt
their doctor places "a great deal" of
importance on cognitive symptoms. The affective and cognitive problems associated with
schizophrenia
may be important factors in long-term outcome.mblcommunications. Similar to our
track record in
epilepsy, Cyberonics' post-approval TRD development plan goes
well beyond the FDA approval requirements
and includes mechanism of action
research and several clinical studies all within the TRD approved
indication
for use.
The VNS Therapy System has been approved for sale in the European Economic
Area and in Canada as a treatment for depression in patients with treatment-
resistant or treatment
-intolerant major depressive episodes, including
unipolar depression and bipolar disorder (manic depression
) since 2001. Our actual
results may differ materially.
depression stigma
2005;10(2 Suppl 1):1-16).
About the Survey
Harris Interactive conducted the "Optimizing Treatment in Schizophrenia
Survey
" online from October 27 - November 15, 2004, among 139 U.
"Cyberonics' mission is to improve
the lives of people touched by
pharmaco-resistant epilepsy and treatment-resistant depression," commented
Robert P. The VNS Therapy System delivers
preprogrammed intermittent mild electrical pulses to
the vagus nerve in the
patient's neck 24 hours a day. For more information on VNS
Therapy for
treatment-resistant depression, including the contraindications,
warnings and precautions, see the
Physician's and Patient's Manuals and other
information at http://www. Investors are cautioned that
all such
statements involve risks and uncertainties, including without limitation,
statements
concerning epilepsy patients maintaining universal access to VNS
Therapy, TRD patients gaining access
to VNS Therapy through case-by-case
approvals or national coverage policies, TRD patients gaining
similar
insurance coverage for VNS Therapy services as Americans with epilepsy and/or
Cyberonics
' funding or completing post-approval TRD studies.deciphered depressed
Cyberonics Announces Closure of Investigational Device
Exemption (IDE) for Treatment-Resistant Depression (TRD) Lifetime Reimbursement Guarantee for All TRD
I
Epilepsy is the second most
prevalent neurological disorder.recognizable antidepressants
Comprehensive treatment of
all schizophrenia symptoms is possible and many
people with schizophrenia can now recover in ways
not previously thought
possible, according to the panel of nationally recognized psychiatrists and
psychologists whose discussions and recommendations are published in a
supplement to the current
issues of Primary Psychiatry and CNS Spectrums
(CNS Spectr.
"Traditionally, physicians have
been oriented to treating schizophrenia by
preventing symptoms from getting worse, rather than helping
the person
continue to get better beyond their current level of symptoms and
functioning," said
Peter J. Lack of access to the only FDA-approved treatment option
for TRD can, unfortunately, have
tragic implications for Americans and their
families. "Studies under an Investigational Device Exemption
are
done to demonstrate the safety and effectiveness of devices for a proposed
indication for
use.delusion treatable
com/proceedings.
In addition to Drs. Buckley, MD,
professor and chairman of the Department
of Psychiatry and Behavioral
Health at the Medical College of Georgia, is also an author of the
statement.com.aspx )
and several State Medicaid programs now have the same coverage policy for
both
epilepsy and depression, all Americans with TRD do not yet have the same
immediate, universal
access to VNS Therapy that Americans with pharmaco-
resistant epilepsy have had for at least the
past five years. Cummins. The purpose of these post-approval studies is to facilitate
fully-informed
use of VNS Therapy for the approved indication consistent with
our mission to improve the lives of
people touched by TRD.delusion antidepressants
Weiden, MD, professor of psychiatry and
director of the Schizophrenia Research
Service at State University of New
York (SUNY) Downstate Medical Center in Brooklyn, an author of
the
statement. Ginsberg, MD,
director of Outpatient Services, Tisch Hospital Department of Psychiatry
at
New York University Medical Center and section editor of MBL
Communications, Inc. Weight gain
in
particular has become a problem with some medications. Source of
survey: "Optimizing Treatment
in Schizophrenia Survey, November 2004. "Official closure by FDA of all TRD studies conducted
under
an Investigational Device Exemption, the lifetime reimbursement
guarantee for TRD IDE study patients
and the $15 million TRD Indigent Access
Program will facilitate accomplishment of that mission by
providing more
Americans with TRD access to the first and only FDA-approved treatment option
for
their lifelong and life-threatening illness. The combination
of FDA approval, FDA's Summary of Safety
and Effectiveness, the official
closure by FDA of all VNS Therapy TRD investigational studies, the
rapidly
building body of peer-reviewed evidence and post-approval appropriate use and
favorable
patient outcomes should convince all third party payers that VNS
Therapy, the first and only treatment
specifically developed, studied,
approved and labeled for TRD, should be a covered benefit as indicated
for
fully-informed use. Cyberonics has taken the unprecedented steps with its lifetime
reimbursement
guarantee for study patients and its $15 million TRD Indigent
Access Program, to ensure that study
patients and indigent Americans with TRD
have fully informed access to VNS Therapy. Stimulation
is delivered by the VNS Therapy System(TM), an implantable
generator similar to a cardiac pacemaker
.
The VNS Therapy System was approved by the FDA on July 15, 2005 "as an
adjunctive long-term
treatment for chronic or recurrent depression for
patients 18 years of age and older who are experiencing
a major depressive
episode and have not had an adequate response to four or more adequate
antidepressant
treatments.depression healthyplace
Schooler, PhD, adjunct professor of psychiatry at
Georgetown University School of Medicine
, an author of the statement., publishers of Primary Psychiatry and CNS Spectrums. Fortunately, at least
two of the newer medications are not
associated with weight gain.
About Schizophrenia
Schizophrenia is a seriously debilitating mental illness characterized by
distortions of reality
and disturbances in perception, mood, cognition,
motivation, social function and motor behavior.
S. adults
18+ who have been diagnosed with schizophrenia, who have switched
schizophrenia medications
at least once and who were members of the Harris
Interactive Chronic Illness Panel. ("Skip") Cummins
, Cyberonics' Chairman of the Board and Chief
Executive Officer. To date, more than 32,000 epilepsy
patients in 24 countries have
accumulated over 94,000 patient years of experience using VNS Therapy
. These statements can be
identified by the use of forward-looking terminology, including "may,"
"believe," "will," "expect," "anticipate," "estimate," "plan," "intend," and
"forecast," or other
similar words.recognizable webworld
A copy of the supplement can also
be accessed at http://www.mblcommunications.php3
. Harvey, PhD,
professor of psychiatry at Mount Sinai School of Medicine and chief
psychologist
at Mount Sinai Hospital, an author of the statement."
About MBL Communications
MBL Communications
, Inc.helphorizons treatable
"We
believe it is important for doctors to look beyond the control of positive
symptoms
and consider the affective/cognitive benefits of medication to
help patients achieve a 'functional
' recovery. In a large-scale study, patients who had
not responded well to prior treatment with risperidone
, olanzapine, or
conventional antipsychotics were switched to ziprasidone, one of the newer
atypical
antipsychotics, and showed statistically significant improvement
in cognitive symptoms. Primary
Psychiatry addresses the
significant comorbid interface between psychiatry and primary care
medicine
. The Company's initial market was epilepsy, a
disorder characterized by recurrent seizures. For
additional information please
visit us at http://www.webworld antidepressant
CNS Spectrums -- The International Journal
of Neuropsychiatric
Medicine -- is a monthly Index Medicus/MEDLINE journal designed to bridge
the
clinical information needs of 48,000 US-based psychiatrists and
neurologists. (Nasdaq: CYBX)
today
announced that FDA recently approved its request to officially close
Investigational Device Exemption
(IDE) G980099 covering all pre-market studies
of VNS Therapy(TM) in chronic or recurrent treatment
-resistant depression
including the D-01 pilot study, the D-02 Pivotal Study and the D-20 Treatment
IDE.delusion pmdd
"But we now know that by taking a long-term focus and tackling
a broader range of symptoms
, many patients do steadily improve so that they
can function better, and live fuller, more complete
lives. please visit: www.com . For a detailed discussion of these and other
cautionary statements
, please refer to Cyberonics' most recent filings with
the SEC, including its Form 10-K for the fiscal
year ended April 29, 2005.antidepressant debunked
The authors advise that factors such as side
effect profiles are predictable
and individual preferences should be
considered.
"All Americans with TRD should have access
to VNS Therapy for its
FDA-approved indication," continued Mr. Consistent with the
post-market
requirements of the majority of device approvals over the past
five years, Cyberonics is required
by FDA to conduct post-market studies. In some cases, depression can last for months or even years.
deciphered depressed
"
Studies suggest that atypical antipsychotics improve cognition better than
older antipsychotics
, but even atypical antipsychotics differ in their
ability to treat these symptoms. HOUSTON, Cyberonics
, Inc. To ensure
that all TRD IDE study patients continue to have access to VNS Therapy,
Cyberonics
also announced today that it is providing a lifetime reimbursement
guarantee to all study patients
and VNS Therapy service providers, whereby
Cyberonics will provide reimbursement for VNS Therapy
services at standard
rates in the event that third party payers deny post-approval coverage to
patients
in the D-01, D-02 and D-20 studies.
Wilder Therapy Access Program in epilepsy, to provide indigent
Americans with
TRD access to VNS Therapy.
depression crosslinked
People with schizophrenia agree with the optimistic
views expressed in the
consensus statement. Most people tend to feel depressed at one time or another
, but some people may experience these feelings more frequently or with deeper, more lasting, effects
.
debunked depressionet
Treatment of schizophrenia has largely focused
on controlling positive symptoms, such as hallucinations
and delusions,
while another set of symptoms that are equally important to patients is
frequently
overlooked by physicians, according to the findings of a new
national consumer survey and the authors
of a new consensus statement aimed
at raising the bar for the treatment of the brain disease.
-- Among those taking antipsychotics, 77% said their medication does not
adequately help
their ability to focus and concentrate.
"Failure to control the affective and cognitive disease
symptoms is one of
the biggest barriers preventing many patients today from achieving a
meaningful
social and occupational recovery," said Philip D.
A person experiencing severe depression may experience
extreme fluctuations in moods or even a desire for complete withdrawal from daily routine and/or the
outside world.
crosslinked measurable
Schizophrenia affects
approximately one in every 100 people. No weighting was applied
to these
results, which have a sampling error of +/-10 percentage points. Primary Psychiatry --
The Leading Voice of Clinical Psychiatric
Medicine -- is the largest circulation, peer-reviewed psychiatric
journal
in the United States, with a monthly circulation of over 65,000 primary
care physicians
and psychiatrists. Cyberonics was recently made aware of one person with three
children who had
suffered from treatment-resistant depression for over 25
years who committed suicide following a
VNS Therapy coverage denial by a major
private payer. In
our case, we originally planned, and
were subsequently required by FDA's
approval order, to conduct a dosing study and long-term patient
outcome
registry to elucidate the optimal dosing, predictors of response and long-term
outcomes
of patients treated with post-approval VNS Therapy. was founded in 1987 to design, develop and market
medical
devices for the long-term treatment of epilepsy, depression and other chronic
treatment
-resistant disorders using a unique therapy, vagus nerve stimulation
(VNS). The Cyberonics VNS Therapy
System was
approved by the FDA on July 16, 1997 for use as an adjunctive therapy in
reducing the
frequency of seizures in adults and adolescents over 12 years of
age with partial onset seizures
that are refractory to antiepileptic
medications.affective melancholia
The supplement and consensus statement were
developed to encourage
physicians to address the debilitating effects of depression, cognitive
impairment
and other aspects of the disease that dramatically impact the
quality of life for people with schizophrenia
," said David L.J.measurable miep
Yet "dealing with affective and
cognitive impairment has not yet become prominent
on the clinical horizon,"
according to Nina R.
-- Yet patients report that it is as important
to control affective and
cognitive symptoms such as depression (77%), problems doing daily
activities (85%), and inability to focus/concentrate (81%), as it is to
control hallucinations
and delusions (84%).
The Optimizing Treatment of Schizophrenia: Enhancing Affective/Cognitive
and Depressive Functioning supplement and survey are sponsored by Pfizer
Inc and coordinated by
Chandler Chicco Agency.vnstherapy. We have no plans and there are no FDA requirements for
Cyberonics
to conduct further depression studies of VNS Therapy as an
investigational device for its approved
indication."
ABOUT VNS THERAPY AND CYBERONICS
Cyberonics, Inc.
VNS Therapy
is at various levels of investigational clinical study as a
potential treatment for anxiety disorders
, Alzheimer's disease, chronic
headache/migraine and bulimia.delusion stigma
Working overtime to stay the Web's best reference!
-> Show SiteSeek's List of Web Sites For This Topic (Not Yet Peer Reviewed)
Loading...
(Note: These pages use the Atlas Content Safeguard System (ACSS) and require that Javascript is enabled for viewing.)