FDA Clears NeuroStar(R) TMS Therapy For The Treatment Of Depression

Neuronetics, Inc., a
privately-held medical device company and a leader in the field of
neuromodulation, announced today that the U.S. Food and Drug Administration
(FDA) has cleared its NeuroStar TMS (Transcranial Magnetic Stimulation)
Therapy system for the treatment of depression. NeuroStar TMS Therapy(R) is
specifically indicated for the treatment of Major Depressive Disorder in
adult patients who have failed to achieve satisfactory improvement from one
prior antidepressant medication at or above the minimal effective dose and
duration in the current episode. In clinical trials with NeuroStar TMS
Therapy, these patients had been treated with a median of 4 medication
treatment attempts, one of which achieved criteria for adequate dose and
duration.



"Clinical neuroscience advances have greatly improved the diagnosis and
treatment of depression, but much more is needed. These disorders lead the
world in producing disability, and more than half of the millions being
treated for clinical depression currently fail to achieve wellness," said
John Greden, MD, Professor of Psychiatry & Clinical Neurosciences and
Executive Director of the University of Michigan Comprehensive Depression
Center. "Before now, few options have been available for them other than
complex and often unproven combinations of medications. Now, with the FDA
clearance of NeuroStar TMS Therapy, there is new hope."



The NeuroStar TMS Therapy system is the first and only TMS Therapy(R)
device cleared by the FDA for the treatment of depression. TMS Therapy is a
non-systemic (does not circulate in the bloodstream throughout the body)
and non-invasive (does not involve surgery) form of neuromodulation which
stimulates nerve cells in an area of the brain that is linked to
depression, by delivering highly focused MRI-strength magnetic pulses.
Patients being treated by NeuroStar TMS Therapy do not require anesthesia
or sedation and remain awake and alert. It is a 40-minute outpatient
procedure that is prescribed by a psychiatrist and performed in a
psychiatrist's office. The treatment is typically administered daily for
4-6 weeks.



"In the randomized controlled trial conducted for FDA clearance,
NeuroStar TMS Therapy demonstrated statistically and clinically significant
treatment effects," said Phil Janicak, MD, Professor of Psychiatry at Rush
University-Chicago and a Principal Investigator in the NeuroStar TMS
Therapy clinical trials. "It's particularly noteworthy that these outcomes
were achieved without systemic side effects, such as weight gain and sexual
dysfunction."



Clinical Trials Demonstrated Efficacy and Safety of NeuroStar TMS
Therapy



NeuroStar TMS Therapy was evaluated for efficacy, safety, and
tolerability in the acute treatment of major depression in patients who had
failed to receive benefit from prior antidepressant medications. A 6-week,
randomized, placebo-controlled, double-blind, study was conducted to
evaluate the safe and effective use of NeuroStar TMS as a monotherapy. An
analysis for predictors of response demonstrated that the patients with the
best response to NeuroStar TMS Therapy were those who had not benefited
from one prior antidepressant medication at an adequate dose and duration
in the current episode. These are the patients for whom NeuroStar TMS
Therapy has been cleared by the FDA.
















This clinical study population was comprised of 164 patients with
unipolar, non-psychotic major depressive disorder. Almost all of them (97%)
had suffered previous depression episodes. These patients also had an
extensive treatment history without a satisfactory improvement. They had
received a median of 4 total prior antidepressant treatment attempts in the
current episode, one of which achieved treatment adequacy at or above the
minimal effective dose and duration. Forty-eight percent were unemployed
due to their depression, 35% had a co-morbid anxiety disorder, and all had
moderate to severe depressive symptoms.



In the indicated patient population, the following efficacy results
were observed in the randomized, controlled study:


-- The primary efficacy measure, the Montgomery-Asberg Depression Rating
Scale (MADRS) symptom score change at 4 weeks, was statistically
significantly superior to placebo (p=0.0006), among NeuroStar-treated
patients. Similar results were observed with the Hamilton Depression
Rating Scale (HAMD).


-- NeuroStar TMS Therapy-treated patients had statistically significant
response and remission rates, which were approximately twice the rate of
placebo-treated patients. The response rate is the percentage of
patients who had a greater than or equal to 50% improvement in symptoms,
and the remission rate is the percentage of patients who achieved
virtually complete symptom resolution.


-- NeuroStar TMS Therapy also produced statistically significant
improvements on the HAMD factor scores for core depression symptoms,
anxiety symptoms, somatization, and psychomotor retardation.



Throughout the NeuroStar TMS Therapy studies, more than 10,000 active
TMS treatments were safely performed. The following were the safety results
observed:



-- No systemic side effects, such as weight gain, sexual dysfunction,
sedation, nausea, or dry mouth


-- No adverse effects on concentration or memory


-- No seizures


-- No device-drug interactions


-- The most common adverse event related to treatment was scalp pain or
discomfort at the treatment area during active treatments, which was
transient and mild to moderate in severity. The incidence of this side
effect declined markedly after the first week of treatment.


-- There was a less than 5% discontinuation rate due to adverse events.


-- During a 6-month follow-up period, there were no new safety observations
compared to those seen during acute treatment.



NeuroStar TMS Therapy is contraindicated in patients with implanted
metallic devices or non-removable metallic objects in or around the head.
As with any antidepressant treatment, patients should be monitored for
symptoms of worsening depression. NeuroStar TMS Therapy has not been
studied in patients who have not received prior antidepressant treatment.
Efficacy has not been established in patients who have failed to receive
benefit from two or more prior antidepressant treatments at minimal
effective dose and duration in the current episode.



"Depression is a debilitating illness, and existing treatment options
are frequently ineffective or intolerable due to side effects," said
Neuronetics' President and CEO, Bruce Shook. "The availability of NeuroStar
TMS Therapy means that patients suffering from this disease now have an
entirely new non-systemic and non-invasive treatment option that has been
proven safe and effective."



Availability of NeuroStar TMS Therapy



Initially, NeuroStar TMS Therapy will only be available in a limited
number of treatment centers around the country.



About Depression



Depression affects at least 14 million American adults each year.
Researchers estimate that by the year 2020, depression will be the second
leading cause of disability worldwide. Each year, over 30,000 people in the
U.S. commit suicide, 60% of which suffer from depression. The economic
burden of depression in 2000 was estimated at $83.1 billion in the U.S.
Women are almost twice as likely as men to suffer from depression. However,
some experts feel that depression in men is under-reported. Depression has
no racial, ethnic, or socioeconomic boundaries. About two-thirds of those
who experience an episode of depression will have at least one other
episode in their lives. Despite major advances in treating this
debilitating illness, nearly 30% of patients with depression do not benefit
from or are intolerant of antidepressant therapy.



About Neuronetics



Neuronetics, Inc. is a privately-held medical device company focused on
developing non-invasive therapies for psychiatric and neurological
disorders using MRI-strength magnetic field pulses. Based in Malvern, PA,
Neuronetics is the leader in the development of TMS Therapy, a non-invasive
form of neuromodulation. For more information, please visit
neuronetics.



NeuroStar(R), NeuroStar TMS Therapy(R), and TMS Therapy(R) are
registered trademarks of Neuronetics, Inc.


Neuronetics, Inc.

neuronetics