Janssen has received US Food and Drug Administration (FDA) approval for its Spravato (esketamine) CIII nasal spray, in combination with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behaviour.
The approval is based on two phase 3 clinical trials in which Spravato, plus comprehensive standard-of-care, demonstrated a significant and rapid reduction of depressive symptoms within 24 hours.
Treatment with Spravato plus standard-of-care led to a 15.9 and 16.0 point decrease on the Montgomery-Åsberg Depression Rating Scale (MADRS) – a commonly-used tool for the assessment of depressive symptom severity – in both trials at the 24-hour time point following the first dose.
In the trials, 41% and 43% of patients treated with Spravato plus standard-of-care achieved clinical remission of depression by the end of the double-blind period, compared with 34% and 27% in the placebo groups in the two trials, respectively.
The safety profile of Spravato was consistent with previous studies of the nasal spray in treatment-resistant depression, with the most common side-effects including dissociation, dizziness, sedation, increased blood pressure, hypoesthesia, vomiting, euphoric mood and vertigo.
"People living with major depression need more options to meet their most critical needs, and we're proud to help redefine how we treat ongoing and acutely worsening depressive symptoms," said Bill Martin, Global Therapeutic Area Head, Neuroscience, Janssen Research & Development.
"Spravato can now help patients with challenging to treat depression find significant and swift relief from debilitating depressive symptoms, offering those living with this serious mental health condition the possibility of a better future," he added.