FDA Clears Neurostar® 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® 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® 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,
study1 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
episode2. These are the patients for whom NeuroStar TMS Therapy has been cleared
by the FDA.















This clinical study population2 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) 3.


- NeuroStar TMS Therapy-treated patients had statistically significant response3
and remission4 rates, which were approximately twice the rate of placebo-treated
patients. The response rate is the percentage of patients who had a >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.4


Throughout the NeuroStar TMS Therapy studies, more than 10,000 active TMS
treatments were safely performed. The following were the safety results observed5:


- 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. For specific information on treatment locations with
NeuroStar TMS Therapy, please visit NeuroStarTMS.


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 US commit suicide, 60% of which
suffer from depression. The economic burden of depression in 2000 was estimated at
$83.1 billion in the US. 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.

References


1. O'Reardon, J,et al. Efficacy and Safety of Transcranial Magnetic Stimulation Therapy in the Acute Treatment of Major
Depression: A Multi-site Randomized Controlled Trial. Biological Psychiatry, December 2007; 62:1208-1216.


2. Lisanby, S, et al. Daily Left Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS) in the Acute Treatment of
Major Depression: Clinical Predictors of Outcome in a Multisite, Randomized Controlled Clinical Trial.
Neuropsychopharmacology, advance online publication, 13 August 2008; doi:10.1038/npp.2008.118.


3. Thase M, Demitrack M. Evaluating Clinical Significance of Treatment Outcomes in Studies of Resistant Major
Depression, Biological Psychiatry, April, 2008; Vol. 63:7s, pg. 138s.


4. Data on file.


5. Janicak, P, et al. Transcranial Magnetic Stimulation (TMS) in the Treatment of Major Depression: A Comprehensive
Summary of Safety Experience from Acute Exposure, Extended Exposure and During Reintroduction Treatment. Journal
of Clinical Psychiatry, February 2008; 69:2:222-232.


NeuroStar®, NeuroStar TMS Therapy®, and TMS Therapy® are registered trademarks of Neuronetics, Inc.

Neuronetics