Why Spravato®
The STAR*D trial demonstrated that the more antidepressants a patient trial’s the less likely they are to respond overall. By the point a patient tries 3 antidepressant’s the remission rate is only about 15% with another treatment trial. Of the patient’s who respond remit at level 3 of 4, 60-70% will relapse within 6 months.
How effective is Esketamine in this population?
There have been multiple phase 3 studies showing esketamine is effective for treatment resistant depression. 65% of participants achieved a 50% or greater decrease in MADRS score. 32% of participants achieved a MADRS total score of 10 or less on day 74, which suggests no-to-mild depression.
The most recent study – SUSTAIN-3 followed the response of patients with TRD treated with esketamine plus an oral antidepressant for 31.5 months.
During this time, the mean Montgomery–Åsberg Depression Rating Scale (MADRS) total score decreased during induction, as well as during optimization/maintenance with 35.6% and 46.1% of participants in remission (MADRS total score ≤12) at induction and optimization/maintenance endpoints, respectively.
The response actually became better with time.
No new safety signal was identified during long-term treatment (up to 4.5 years) using intermittent-dosed esketamine in conjunction with daily antidepressant.
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What to know (12 essentials of Esketamine)
1) Esketamine nasal spray (Spravato®) is the only FDA-approved ketamine-based depression treatment. Esketamine is the S-isomer of ketamine.
2) Esketamine, like ketamine, has an entirely unique mechanism of action partially based on N-methyl-D-aspartate (NMDA) glutamate receptor antagonist and presynaptic increases in glutamate.
3) It acts rapidly without side effects of other antidepressants like weight gain or sexual disfunction.
4) Esketamine is FDA-approved for treatment-resistant depression (TRD) and depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation.
5) Esketamine or Spravato® must be used in conjunction with an oral antidepressant. It does not replace anyother medication and is not considered solo therapy!
6) Spravato® is only available at qualified sites under a Risk Evaluation and Mitigation Strategy (REMS) Program overseen by the DEA.
7) Spravato® has widespread coverage by most insurances following:
-two failed antidepressant trials in combo with
-two augmentive agents
8) Spravato® is self adininstered by the patient in an outpatient setting.
9) The average treatment duration is 2 hours. A typical treatment schedule is:
• Phase 1 Induction: 2 treatments a week for 4 weeks
• Phase 2 Transition: 1 treatment a week for 4 weeks
• Phase 3 Maintenance: 1 treatment every 1-2 weeks
10) The most common side effect is dissociation (73%) occurrring more frequently than sedation (22%) with most symptoms resolving by 2 hours. Patients were reported to be ready to leave approximately 90 minutes after dosing.
11) Who shouldn’t have esketamine?
• History of abnormal blood vessels, such as an Arteriovenous Malformation or Aneurysm
• History of hyper-sensitivity to esketamine or ketamine
• High blood pressure that is not currently under control with medications or lifestyle management
When to refer?
The majority of medical policies from diffeent carriers ask for a patient to trial 3 antidepressants in 2 or more classes, and 2 augmentive agents. It’s striking that Spravato, even in the TRD population, has efficacy. If your patient hasn’t improved with 3 or more medications, please consider Spravato®.
The reponse was stronger wtih continued treatment.
