SUMMARY  

• The number needed to treat (NNT), number needed to harm (NNH), and the likelihood to be helped or harmed (LHH) were calculated for patients with treatment-resistant depression managed with SPRAVATO nasal spray plus a new oral antidepressant (SPRAVATO+AD) vs placebo nasal spray plus a new oral antidepressant (PBO+AD).¹  The post hoc analysis was based on 3 randomized, double-blind, short-term studies (TRANSFORM-1, 2, and 3)^2-4 and a long-term, randomized-withdrawal maintenance study (SUSTAIN-1).⁵ Results were calculated for the individual studies and were pooled based on the short-term studies.
  • The analysis reported NNT values ≤10 for efficacy outcomes based on the pooled, short-term TRANSFORM studies, indicating potential benefits of SPRAVATO+AD versus PBO+AD.  From the long-term SUSTAIN-1 study, the NNT for remission (MADRS total score <12) was 5.
  • Discontinuation rates due to adverse events (AEs) for the pooled TRANSFORM studies were 4.8% in the SPRAVATO-treated patients and 1.7% in the PBO-treated patients. Based on these rates, the NNH vs PBO was 33 (statistically significant) for the pooled TRANSFORM studies. The NNH vs PBO was 178 for the SUSTAIN-1 study (not statistically significant) due to the low discontinuation rates in either arm.
  • Based on the pooled TRANSFORM studies, the LHH vs discontinuation due to AEs was 33/10 or 3.3. Therefore, patients receiving SPRAVATO+AD were three times more likely to achieve acute remission versus discontinue due to an adverse event.
• In a meta-analysis of randomized, nominally double-blinded, short-term (≤12 weeks), placebocontrolled clinical studies (including data from a phase 2 study; the TRANSFORM-1, 2, and 3 studies; and the ASPIRE-I and II studies)^2-4,6-9 evaluating the efficacy and tolerability of specific drug combinations in patients with major depression, the NNT for response for SPRAVATO+AD was reported as 7 (95% confidence interval [CI], 5-10).¹⁰

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 07 March 2024.