5 Key Takeaways

• 1

  A systematic review questioned the clinical efficacy of esketamine nasal spray for treatment-resistant depression and suicidal ideation.

• 2

  The review highlighted modest effect sizes and a lack of controlled long-term efficacy data for esketamine.

• 3

  Concerns were raised about the FDA's approval process, which relied on a randomized withdrawal trial rather than traditional efficacy studies.

• 4

  Postapproval data showed mixed results, with increases in suicidal ideation but no increase in suicide attempts.

• 5

  Esketamine prescriptions have nearly doubled since early 2023, with over 2,800 clinics now offering the treatment.