FDA approves esketamine nasal spray for refractory depression


  • The FDA has approved esketamine nasal spray, Spravato (Janssen Pharmaceuticals), for treatment-resistant depression.

Why this matters

Key highlights

  • Indication is for adults with depression for whom ≥2 other antidepressant medications have failed.
  • It is to be taken with an oral antidepressant.
  • A black box warning accompanies approval because of serious adverse event risk, including for sedation, abuse, and suicidal thoughts and behaviors.
  • The spray is also subject to restricted distribution under a Risk Evaluation and Mitigation Strategy (REMS):
    • REMS requirements include patient commitment not to drive or use heavy machinery on the day of administration.
    • Health care providers are to monitor patients for 2 hours after self-administration of the spray, which cannot be taken home.
  • Supporting evidence:
    • Short-term placebo-controlled trial: effect was detected within 2 days in some cases.
    • Results of 2 other short-term trials did not meet threshold for statistical effect.
    • Long-term trial suggested stable remission or response, latency to relapse with treatment.
  • Side-effects include dissociation, dizziness, increased BP, feeling inebriated.
  • Spray is contraindicated in pregnancy and with breastfeeding and may increase risk for vascular events in patients with existing disease.

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