Nevertheless, Esketamine doesn't appear to be any more effective than its less expensive alternatives.
You're testing whether the drug works within a subset of known Esketamine responders," said Turner.
However, he said,
certain factors related to these"unique phase 3 studies" of Esketamine may have contributed to this.
In another, the response for Esketamine was even lower(8%) and,
compared with placebo response(5%), was nonsignificant, he said.
If the agency agrees, Esketamine will be the first approved new medication in
decades to treat severe depression.
Sanacora believes this is what the FDA's advisory committees did in arriving at the decision to approve Esketamine.
What was less clear- and of significant importance- was if patients who improved on Esketamine
could remain depression-free long-term taking Esketamine.”.
A meta-analysis using the primary outcome results of the three Esketamine trials"yields a standardized mean difference of 0.28(95% confidence interval,
0.11- 0.44)," writes Turner.
In this study, there was a faster relapse in those on placebo than on Esketamine(within 2-4 weeks compared with the typical 1 month
or more).
I am not a big fan" of the widespread use of atypical
antipsychotics in depression,"but I don't see evidence that Esketamine is a better alternative,
While some experts have hailed intranasal Esketamine(Spravato, Janssen)
as a"game changer" for treatment-resistant depression(TRD), others are concerned over the US Food and Drug Administration's(FDA) rapid approval of the drug.
I don't support the idea of approving a treatment with subpar efficacy because other medications for treatment-resistant
depression don't work very well and Esketamine has a different mechanism of action," he said.
In addition, he pointed to evidence suggesting patients with three or more previous treatment failures may
actually show an enhanced response to an antidepressant plus Esketamine compared with an antidepressant plus placebo.