Janssen’s party drug-based nasal spray becomes first new FDA-approved depression treatment in 30 years
pharmafile | March 6, 2019 | News story | Research and Development, Sales and Marketing | Janssen, Spravato, depression, esketamine, pharma
The field of depression therapy has seen its biggest leap forward in over three decades, the FDA approval of Janssen’s CIII nasal spray Spravato (esketamine), a chemically similar form of the recreationally-used ketamine, in treatment-resistant forms of the condition.
The drug is authorised for use alongside an oral antidepressant in patients who have “cycled through multiple treatments without relief”, according to the manufacturer, referring to those who have responded inadequately to at least two different antidepressant medications in the current depressive episode; it is thought that this represents around a third of patients with major depressive disorder.
Spravato was tested in over 1,700 patients, demonstrating “superior improvement” in the symptoms of depression after four weeks of treatment in combination with an oral antidepressant compared to placebo combined with an oral antidepressant; it was found that those patients in stable remission and containing to take the combo were 51% less likely to relapse.
The drug acts on the N-methyl-D-aspartate (NMDA) receptor in the brain, presenting the first new mechanism of action in the treatment of depression in 30 years. Delivered twice weekly at a specialised treatment centre, patients reported side-effects ranging from vomiting and lack of energy to dissociation and feeling drunk. Patients are monitored for at least two hours following administration to ensure they are safe to leave.
“Depression is a common and potentially debilitating illness that can have profound emotional, functional and economic impact on both those who suffer and their loved ones. The impact of depression is greatest for those who do not benefit from standard treatments,” explained Dr Michael E Thase, Site Prinicipal Investigator for the trials and a Professor of Psychiatry and Director of the Mood and Anxiety Disorders Treatment and Research Program in the Perelman School of Medicine, University of Pennsylvania. “In Phase 3 clinical trials, we saw this therapy provide sustained improvement to patients with treatment-resistant depression.”
“Spravato has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies,” added Dr Mathai Mammen, Global Head at Janssen Research & Development. “This unique and innovative medicine is a testament to Janssen’s heritage of advancing solutions in neuroscience to heal minds and improve health outcomes.”
Matt Fellows
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