Transcranial Magnetic Stimulation (TMS) & SPRAVATO®

SPRAVATO® is for use alone or in combination with an oral
antidepressant for:

• Adults with treatment-resistant depression (MDD patients who
  have had an inadequate response to 2 or more oral ADs)

SPRAVATO® is for use in combination with an oral antidepressant for:

• Depressive symptoms in adults with MDD with acute suicidal
  ideation or behavior (MDSI)

In TRD, the new open-label oral AD initiated during Study 1 (short-term)
was an SSRI in 32% of patients and an SNRI in 68% of patients.
In MDSI trials for adults with MDSI, all patients received comprehensive
standard-of-care treatment, including an initial inpatient hospitalization
and a newly initiated or optimized oral AD therapy as determined by
the investigator.
SSRI=selective serotonin reuptake inhibitor.
SNRI=serotonin and norepinephrine reuptake inhibitor.

No, under the REMS, SPRAVATO® must be administered in a certified
healthcare setting. Due to the possibility of delayed or prolonged
sedation or dissociation in some cases, patients should be monitored
by a healthcare provider for at least 2 hours following each treatment
session, or until the clinician determines the patient is safe to leave.
SPRAVATO® is also administered under REMS due to the potential for
abuse and misuse. Patients must be monitored for signs and
symptoms of abuse and misuse.

SPRAVATO® may impair ability to drive or operate machinery. Patients
should not engage in potentially hazardous activities requiring
complete mental alertness and motor coordination, such as driving a
motor vehicle or operating machinery, until the next day after a restful
sleep

SPRAVATO® (esketamine) nasal spray is the S-enantiomer of racemic
ketamine. SPRAVATO® is an FDA-approved nasal spray for treatment
resistant depression (TRD) and major depressive disorder (MDD) with
acute suicidal ideation or behavior (MDSI). Ketamine has not been
approved by the FDA to treat depression. There are no head-to-head
studies comparing esketamine and ketamine infusion. Both
SPRAVATO® and ketamine are Schedule III controlled substances
under the U.S. Controlled Substances Act.

TMS treatment is normally spread out over four-to-six weeks. During
this time, patients come in for sessions five times per week and each
of these sessions last about 20 minutes. Depending on the mental
health condition being treated, there may be additional maintenance
sessions after the initial course of treatment.

Typically, patients hear a tapping sound and feel a tapping sensation in
the head area during TMS therapy session. To diminish the sound, the
patient is provided with earplugs. Some patients experience
temporary, mild pain or discomfort in the area of the treatment site,
which occurs during the treatment session. This typically occurs only
during the first week of treatment. Other side effects may include
muscle twitching and jaw pain.

TMS treatment is safe to combine with any sort of medication or
psychotherapy. TMS is both noninvasive and found to be effective in
treating a variety of mental health conditions, in combination with other
forms of therapy or as a standalone treatment.