New Phase 3 data backs up the efficacy of esketamine in treatment-resistant depression

pharmafile | May 21, 2019 | News story | Manufacturing and Production, Research and Development, Sales and Marketing Spravato, depression, esketamine, pharma 

New research has been published on the efficacy of esketamine in the treatment of depression, following its approval from the FDA in the US in combination with oral antidepressants earlier this year.

The findings were drawn from data generated in a Phase 3 trial of the drug, conducted across 39 outpatients centres between August 2015 and June 2017 and involving almost 200 adult participants with moderate to severe depression which had not responded to at least two prior antidepressant treatments.

It was found that those receiving esketamine achieved a “significantly greater” improvement in depression after 28 days of treatment compared to placebo, with similar improvements observed earlier in the study. The esketamine group also experienced a range of side-effects including dissociation, dizziness, nausea, vertigo and distortion of the sense of taste, but they typically resolved within 1.5 hours. However, 7% of patients receiving the drug discontinued the study as a result of side-effects.

The drug’s effectiveness is particularly promising given that as many as a third of those with depression find the condition does not respond to treatment, and the intervention it does provide is fast-acting.

“This trial of esketamine was one of the pivotal trials in the FDA’s review of this treatment for patients with treatment resistant depression. Not only was adjunctive esketamine therapy effective, the improvement was evident within the first 24 hours,” commented study author Dr Michael Thase. “The novel mechanism of action of esketamine, coupled with the rapidity of benefit, underpin just how important this development is for patients with difficult to treat depression.”

Matt Fellows

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