J&J’s Spravato Bests Quetiapine in Phase III Head-to-Head Depression Study
05 Oct 2023
Clinical ResultPhase 3Drug ApprovalPhase 2
Pictured: J&J's business center in Switzerland/iStock, yuelan
Johnson & Johnson’s nasal spray Spravato (esketamine) CIII outperformed extended-release quetiapine at inducing remission in patients with treatment-resistant depression, the company announced Wednesday at the same time the results were published in The New England Journal of Medicine.
These data come from the Phase IIIb ESCAPE-TRD trial, a randomized, open-label and active-controlled study that enrolled 676 patients with treatment-resistant depression (TRD). After eight weeks of treatment, 27.1% of patients treated with Spravato achieved remission, defined as a score of 10 or below on the Montgomery–Åsberg Depression Rating Scale (MADRS), a validated and clinician-rated tool to measure depression severity.
In contrast, only 17.6% of quetiapine comparators reached remission, and the between-group difference was statistically significant, according to J&J’s announcement.
The head-to-head findings from ESCAPE-TRD can provide doctors with “important data to consider in the management of treatment-resistant depression by comparing the short- and long-term effectiveness of Spravato to an oral antipsychotic,” Reina Benabou, vice president of medical affairs at Janssen Scientific Affairs, said in a statement.
In the Phase IIIb study, Spravato and quetiapine were given on top of continuing selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors. In addition to eight-week remission, ESCAPE-TRD also assessed the durability of this effect. Spravato likewise came out on top for this key secondary endpoint, with 21.7% of treated patients remaining relapse-free after 32 weeks, compared to only 14.1% of quetiapine-treated counterparts.
In terms of safety, Spravato’s adverse event pro ESCAPE-TRD was consistent with what had previously been established. There were more treatment-emergent adverse events in the Spravato group, thought study dropouts due to toxicities were more common in the quetiapine arm.
Spravato is an intranasal, non-competitive NMDA receptor antagonist indicated for TRD, and for depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideations or behaviors. The therapeutic nasal spray has not been proven to be effective at preventing suicide or reducing ideations, and its label comes with a boxed warning for dissociation, potential for misuse and heightened risk of suicidal thoughts and behaviors in young patients.
J&J’s Phase III victory announced on Wednesday continues the industry’s winning streak in the neuropsychiatric space. Last week, Bionomics reported positive Phase IIb data for its investigational ion channel modulator in post-traumatic stress disorder. Patients treated with the candidate experienced significant reductions in PTSD symptoms.
The same day, Fabre-Kramer ended its decades-long regulatory odyssey with a victory, nabbing the FDA’s approval for its extended-release gepirone hydrochloride tablets, now under the brand name Exxua, for the treatment of MDD in adults.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
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