FDA Clears NeuroStar(R) TMS Therapy for the Treatment of Depression

First and Only Non-systemic and Non-invasive Treatment Cleared for Patients Who Have Not Benefited From Prior Antidepressant Treatment

MALVERN, Pa., Oct. 8 /PRNewswire/ -- 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. For specific information on treatment locations with NeuroStar TMS Therapy, please visit www.NeuroStarTMS.com or call the Neuronetics Customer Service Center at (877) 600-7555.

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 www.neuronetics.com.

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

SOURCE Neuronetics, Inc.

http://au.sys-con.com/node/703555

Non-Invasive Treatment For Depression - Rush University Medical Center Psychiatrist Led Clinical Trials Of Transcranial Magnetic Stimulation

10 Oct 2008

Transcranial Magnetic Stimulation (TMS) therapy has received clearance from the U.S. Food and Drug Administration (FDA) and is now an entirely new treatment option for patients suffering from depression.

Dr. Phil Janicak, a professor of psychiatry at Rush University Medical Center, was the principal investigator for the clinical trials of TMS, which is a system that uses repeated short bursts of magnetic energy introduced through the scalp to stimulate nerve cells in the brain to alleviate major depression.

TMS therapy, which is developed by Neuronetics, Inc., is an effective, non-drug treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from antidepressant medication.

"In the randomized, controlled trial conducted for FDA clearance, TMS Therapy demonstrated statistically and clinically significant treatment effects," said Dr. Janicak. "It's particularly noteworthy that these outcomes were achieved without systemic side effects, such as weight gain and sexual dysfunction."

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. Throughout the study, more than 10,000 active TMS treatment sessions were safely performed. There were no systemic side effects such as weight gain, sexual dysfunction, sedation, nausea or dry mouth. There were no adverse memory effects, seizures or device-drug interactions. Overall, less than five percent of patients discontinued the study due to adverse events. Also, during the six-month follow-up period, there were no new safety issues compared with those seen during the acute treatment phase.

Patients treated with 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 an outpatient setting. The treatment is typically administered daily for four-to-six-weeks.

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. About two-thirds of those who experience an episode of depression will have at least one other episode in their lives. Depression is a debilitating illness, and existing treatment options are frequently ineffective or intolerable due to side effects. Current antidepressant therapies are not beneficial for at least a third of depressed individuals, leaving many with a lack of adequate treatment options.

"Before now, few options have been available for them other than complex and often unproven combinations of medications," said Dr. Janicak. "Now, with the FDA clearance of NeuroStar TMS Therapy, there is new hope."

RUSH

http://www.medicalnewstoday.com/articles/125049.php

When Nothing Else Works: Therapy Approved By FDA For Treatment-resistant Depression

11 Oct 2008

Millions of patients with treatment-resistant clinical depression, who have struggled for years with disability and how to cope with their condition, now have an option that could help them lead more productive and successful lives.

The NeuroStar TMS (Transcranial Magnetic Stimulation) Therapy system, developed by Neuronetics, Inc. and initiated by research at the Medical University of South Carolina (MUSC), is the first and only approved TMS Therapy® device cleared by the Food and Drug Administration for the treatment of severe depression (Oct. 7). Patients must be adults with major depressive disorder, commonly known as treatment-resistant depression, who have failed to improve their condition with other treatments or medication.

MUSC currently is the only location in South Carolina, North Carolina, Virginia, and Florida with this treatment option for depression. Patients will have access to the therapy at MUSC within two months.

MUSC Distinguished University Professor of Psychiatry and Brain Stimulation Laboratory Director Mark George, M.D., played a major role in developing this technology since its beginnings in the late 1980s.

"Everyone in the Brain Stimulation Laboratory has worked so hard for so many years on these studies," he said. "They all deserve credit, as well as many other colleagues who helped to develop the necessary medical equipment to make this therapy a reality. Despite the gloom and doom that seems to surround us, the world is slightly better today than yesterday, as patients with depression have another option to try and relieve their pain and suffering."

George also credited NARSAD (the world's leading charity dedicated to mental health research) with a large role in advancing the new treatment by providing funding and continued support for the first trials involving this kind of treatment.

In addition to this trial that resulted in FDA approval, MUSC is conducting an NIMH (National Mental Institutes of Health) sponsored, double-blind clinical trial for TMS that will conclude in December. For more information, visit http://clinicaltrials.gov/ct2/show/NCT00149838.

How it works

TMS Therapy is a non-systemic (does not circulate in the bloodstream) and non-invasive (no 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 treated with 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. Cost of the treatment is approximately $200-300 per session.

In the randomized controlled trial conducted for the FDA, the therapy showed significant treatment effects without systemic side effects such as weight gain or sexual dysfunction.

Throughout the NeuroStar TMS Therapy studies, more than 10,000 active TMS treatments were safely performed with:

-- No systemic side effects, such as sedation, nausea, or dry mouth

-- No adverse effects on concentration or memory

-- No seizures

-- No device-drug interactions

-- Mild to moderate scalp pain or discomfort at the treatment area during treatment, which declined after the first week of treatment

-- A less than 5 percent discontinuation rate due to adverse events

-- There were no new safety observations compared to those seen during acute treatment during a 6 month follow-up period

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.

About MUSC

Founded in 1824 in Charleston, The Medical University of South Carolina is the oldest medical school in the South. Today, MUSC continues the tradition of excellence in education, research, and patient care. MUSC educates and trains more than 3,000 students and residents, and has nearly 11,000 employees, including 1,500 faculty members. As the largest non-federal employer in Charleston, the university and its affiliates have collective annual budgets in excess of $1.6 billion. MUSC operates a 750-bed medical center, which includes a nationally recognized Children's Hospital and a leading Institute of Psychiatry. For more information on academic information or clinical services, visit http://www.musc.edu or http://www.muschealth.com.

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 http://www.neuronetics.com.

About NARSAD

For the past 22 years, with the help of thousands of donors, NARSAD has given more than $238 million and 3,516 grants to researchers worldwide who have helped pioneer breakthroughs in deciphering how the brain develops, how its component parts act and how this key organ may differ in people with mental illness. Their efforts have led to new treatments, improved diagnostics and preventative measures for people with a wide range of brain and behavior disorders, including depression, anxiety disorders, PTSD, bipolar disorder, schizophrenia, and childhood mental disorders, such as autism and ADHD, among other conditions affecting adults and children. For more information, visit http://www.narsad.org.

Medical University of South Carolina
171 Ashley Ave.
Charleston, SC 29425
United States
http://www.musc.edu

http://www.medicalnewstoday.com/articles/125149.php

FDA clears treatment for depression

By Jill Coley

The Post and Courier

Monday, October 13, 2008

Clinical trial: To learn more about enrolling in a current National Institute of Mental Health study on transcranial magnetic stimulation for treatment-resistant clinical depression, go to http://tinyurl.com/3wykwd.

One in 20 people suffers from depression. Half of those have an intractable type that will not respond to medicine or talking therapy.

Dr. Mark George, psychiatry professor and director of the Brain Magnetic Stimulation Laboratory at Medical University of South Carolina, has worked for more than a decade developing a new therapy to help depressed patients who are running out of options.

The NeuroStar Transcranial Magnetic Stimulation Therapy system was developed by Malvern, Pa.-based Neuronetics with research that began at MUSC. The Food and Drug Administration cleared the device Tuesday for marketing.

The device basically is a powerful magnet that delivers focused pulses to an area of the brain that is linked to depression. The magnetic pulses stimulate the nerve cells, and through a process not fully understood, the stimulation alleviates symptoms of depression.

It is the first clearance for the marketing of a transcranial magnetic stimulation system for treatment of major depressive disorder, FDA press officer Scott McFarland said.

Previously, the arsenal to help treatment-resistant patients comprised different methods of sending electricity into the brain.

Although several methods exist today, the oldest form is electroconvulsive therapy, known as ECT or "shock therapy," which has a stigma because of its early use without anaesthesia.

In ECT, electrical currents are sent through the brain and trigger a brief seizure. No one knows exactly how the therapy works, only that changes seem to occur in the brain's chemistry in a way that can offer relief for some mental illnesses.

George, a brain imaging expert, said, "I became convinced the seizure didn't matter. The electricity or current to the brain is what matters. Maybe we can just kind of tickle those circuits without turning them off."

Early trials on the technology were carried out with funding from NARSAD, an international charity dedicated to mental health research. The most recent trial was funded by the device manufacturer, and MUSC is conducting another study sponsored by the National Institute of Mental Health.

This gentler approach has fewer side effects than electroconvulsive therapy and takes less time, George said. No anaesthesia is required and no adverse effects on concentration or memory were reported.

"It feels like hitting your head with a hard eraser," he said.

A course of treatment will cost about $6,000, compared to electroconvulsive treatments which can run up to $20,000. "The next big question is will insurance pay for these," George said.

The machine costs between $50,000 and $60,000, George said. The manufacturers have made only 15. MUSC will lease a device and begin treatments in about two months, he said.

Charleston psychiatrist James C. Ballenger recommended a handful of his patients to participate in the manufacturer's trial and described the therapy as "close to being miraculous."

Unlike other forms of brain stimulation treatments, Ballenger said, "The average psychiatrist can have this in his office."

One of his patients had been depressed for 20 years and tried every available medication with only short-term success. "He had an astoundingly positive response," Ballenger said.

In rare instances, the treatment can make changes in a patient's psychology that are unwanted, he said. For example, a bipolar patient may swing from depression to mania.

Reach Jill Coley at 937-5719 or jcoley@postandcourier.com.

http://www.charleston.net/news/2008/oct/13/fda_clears_treatment_depression57659/