- The FDA has approved esketamine nasal spray, Spravato (Janssen Pharmaceuticals), for treatment-resistant depression.
Why this matters
- Approval fills a gap for this patient population, the FDA said in a statement.
- 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.