FDA approves esketamine nasal spray for refractory depression

  • FDA

  • curated by Emily Willingham, PhD
  • Clinical Essentials
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • 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.

Prescribing information, click here .