Johnson & Johnson is developing an inhaled, intranasal formulation of Spravato (esketamine) as a potential adjunctive treatment for major depressive disorder patients who do not respond adequately to conventional antidepressants. The development of Spravato, containing esketamine, is a direct result of previous data suggesting the rapid and large antidepressant effect of the recreational drug ketamine. Ketamine is a racemic mixture that acts as an NMDA receptor antagonist. It is thought that the NMDA receptor and glutamatergic signaling mediate the delayed response of conventional monoaminergic-based antidepressants, and that blocking the NMDA receptor would result in a rapid antidepressant effect. Esketamine is the S-enantiomer of ketamine, with a three-to-fourfold higher affinity for the NMDA receptor than arketamine.
Esketamine is currently being evaluated in a series of large Phase III trials that will determine its efficacy, tolerability, and safety when combined with standard antidepressants. Johnson & Johnson is running both short-term trials over a four-week treatment period, with a twice-weekly dosing schedule, and also longer-term trials that allow for dose reductions to once weekly or fortnightly. Esketamine was awarded breakthrough therapy designation in the US on account of its potential to demonstrate substantial improvement over available therapies, which will allow the US Food and Drug Administration to grant esketamine a priority review. Furthermore, Johnson & Johnson will be able to follow a rolling New Drug Application, and submit for regulatory approval before the completion of its entire TRANSFORM and SUSTAIN clinical program.
LIST OF FIGURES
14 Figure 1: Datamonitor Healthcare’s drug assessment summary of Spravato for depression
15 Figure 2: Datamonitor Healthcare’s drug assessment summary of Spravato for depression
17 Figure 3: Spravato sales for depression across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
6 Table 1: Spravato drug profile
8 Table 2: Late-phase trials of Spravato for depression
11 Table 3: Spravato Phase II trial data in MDD patients at imminent risk of suicide
12 Table 4: Spravato ongoing trials as an adjunct in MDD patients at imminent risk of suicide
13 Table 5: Spravato for depression – SWOT analysis
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