• NeuroStar TMS Therapy was studied in 301 depressed 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 adults 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.

o Patients 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.

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

• The primary efficacy measure was statistically significantly superior to placebo (p=0.0006) among NeuroStar-treated patients.

• NeuroStar TMS Therapy-treated patients had statistically significant response and remission rates, which were approximately twice the rate of placebo-treated patients.

Patients who did not respond in the randomized, controlled study entered into a 6-week, open-label treatment study. In the open-label study, which is most like real-world clinical practice, the following was observed:

• Patients treated for the first time with NeuroStar TMS Therapy achieved a 54% response rate and a 33% remission rate on the HAMD 24-item scale at the end of 6 weeks

• Similar results were observed using the MADRS rating scale.

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

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

• The most commonly reported side effect related to treatment was scalp pain or discomfort during the TMS treatment session.

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

• No seizures were reported.

• Yes, particularly in patients who had failed multiple treatment attempts, one of which achieved an adequate dose and duration

• In the randomized, controlled trial, almost 3x the number of NeuroStar-treated patients had a significant improvement in symptoms as compared to placebo.

o The magnitude of difference between active and placebo treatments  compares favorably to results for most antidepressant medications approved for the treatment of depression, despite the fact that almost all antidepressant medications have been studied and approved for 1st-line treatment.

o In the NeuroStar open-label trial, which is most like the real world, ~1 in 2 patients had a significant improvement and 1 in 3 had complete symptom resolution.

• In addition to efficacy, NeuroStar’s safety/tolerability profile is also clinically meaningful

o It is non-systemic, which means  it does not cause side effects such as weight gain, sexual dysfunction, nausea, dry mouth, or sedation.

o The most commonly reported side effect related to treatment was scalp pain or discomfort during the treatment session.

• Adults
• Unipolar, non-psychotic depression diagnosis

• Had failed at least one, but no more than four, previous medications at an adequate dose and duration in the current episode.

• There were no incidents of reported suicide or suicide attempts in patients treated with NeuroStar TMS Therapy during the clinical trials.

• Patients who were at high risk of suicide were not included in the trial.

• In addition, a careful analysis of the safety data showed that there was no evidence that NeuroStar TMS Therapy was associated with worsening of suicidal ideation during acute treatment.

• NeuroStar TMS Therapy has only systematically been evaluated in patients with unipolar, non-psychotic major depression

• While there is promising data in a variety of other disorders, these data are preliminary and require systematic evaluation in controlled clinical trials

• For information on other potential uses for TMS, contact Neuronetics Customer Service and our Medical Affairs staff can provide you with this information.