Johnson and Johnson’s Spravato (esketamine) received approval in 2019. The treatment was approved for use alongside an oral antidepressant therapy in adults with a moderate to severe episode of major depressive disorder.
In the latest Phase IIIb trials, the treatment was compared against quetiapine extended-release (also known by the brand name, Seroquel XR) – both in combination with a continuing selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), in adults with treatment-resistant major depressive disorder (TRD).
Results of the ESCAPE-TRD trial - presented recently at the DGPPN Congress in Berlin hosted by the German Association for Psychiatry, Psychotherapy and Psychosomatics - found that Spravato demonstrated superior efficacy in achieving remission at week eight compared to quetiapine XR. Further, more participants treated with Spravato remained relapse free up to week 32 of the study.
In the figures provided, this worked out as 27.1% achieving remission at week eight against 17.6%, as well as 21.7% against 14.1% for numbers of people remaining in remission.
Additional follow-up at the week 32 stage of the trial showed that remission rates continued to increase in both arms after the primary endpoint at week eight had passed. The results showed that 55% of patients taking Spravato and 37% of patients on quetiapine XR achieved remission.
The treatment it was measured against in the Phase III trial had previously been owned by AstraZeneca, before it sold off the rights for different regions.
As the product is now off-patent, there are various generic manufacturers of quetiapine extended-release treatments, but the therapy is still widely prescribed as an antipsychotic medication.
J&J stated, “This provides further evidence for the use of esketamine nasal spray in this difficult-to-treat population and offers hope for the millions of people affected by TRD.”
The product itself is delivered through a single-use nasal spray device under the direct supervision of a healthcare professional.
For J&J demonstrating that Spravato is able to outperform traditional antidepressants is essential to persuade payers that the list price represents value for money.
On first releasing the product, the Institute for Clinical and Economic Review (ICER) stated that it was “hard to understand how a price exceeding usual cost-effectiveness thresholds is appropriate for a treatment that could be very widely used.”
As a result, there was some pushback, including by the UK’s NICE, which did not recommend the product for use due to cost-efficacy.
GlobalData estimated that Spravato would likely generate global sales of approximately $383m by 2029. At the time of the product’s approval, there were suggestions that it could onto become a blockbuster treatment due to its potential to improve on existing treatments.
Source: DGPPN 2022
November 23-26, 2022. Poster P-01-04.
"Esketamine nasal spray improves short‑ and long‑term outcomes compared with quetiapine extended release in patients with treatment resistant depression: First results from ESCAPE‑TRD, a randomised, multi‑centre phase IIIb clinical trial"
Authors: A. Reif et al.,