Janssen have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the expanded use of SPRAVATO® (esketamine nasal spray) for the treatment of depressive symptoms.
The spray is to be co-administered with oral antidepressant therapy in adults with a moderate to severe episode of MDD, as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency.3
Across both studies, patients treated with esketamine nasal spray accompanied by comprehensive SOC had a statistically significant and clinically meaningful reduction in depressive symptoms (reduction from baseline Montgomery-Åsberg Depression Rating Scale [MADRS]† total score) at 24 hours after receiving the first dose compared to placebo nasal spray in combination with comprehensive SOC (p=0.006). The benefit of esketamine nasal spray plus comprehensive SOC on symptoms of MDD was apparent as early as four hours after the first dose.1,2 The effectiveness of esketamine nasal spray in preventing suicide or in reducing suicidal ideation or behaviour has not been demonstrated.
The safety profile of esketamine nasal spray in this patient population was consistent with previous studies in adults with treatment-resistant depression (TRD).4,5 The most common treatment-emergent adverse events (≥20%) observed in the esketamine nasal spray plus comprehensive SOC group versus the placebo nasal spray plus comprehensive SOC group during the double-blind phase were dizziness (38.3% vs 13.8%), dissociation (33.9% vs 5.8%), nausea (26.9% vs 13.8%), somnolence (20.7% vs 10.2%), and headache (20.3% vs 20.4%), respectively.6
With this positive CHMP opinion, esketamine nasal spray will now be considered by the European Commission for adults with a moderate to severe episode of MDD, as acute, short term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency. The European Commission has the authority to grant marketing authorisation for medicines in the European Economic Area.
Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Janssen Research & Development, LLC said: “There is a pressing need to provide individuals with Major Depressive Disorder who are experiencing a psychiatric emergency with treatments that can rapidly reduce their depressive symptoms. If approved by the European Commission, esketamine nasal spray has the potential to offer individuals relief from debilitating depressive symptoms and address a key unmet need within this population.”
Allitia DiBernardo, MD, European Therapeutic Area Lead for Mood Disorders, Janssen-Cilag said: “Immediate intervention for individuals living with Major Depressive Disorder who are in a psychiatric emergency is essential. Whilst currently available antidepressants are effective in treating depressive symptomatology, they can often take weeks to achieve their full effects, which limits their utility in acute, emergency treatment.”
References
† The Montgomery-Åsberg Depression Rating Scale (MADRS): A 10-item diagnostic questionnaire that psychiatrists use to measure the severity of depressive episodes in patients with mood disorders
1 Fu DJ, et al. J Clin Psychiatry 2020;81(3):19m13191.
2 Ionescu D, et al. Int J Neuropsychopharmacol 2020;pyaa068.
3 Committee of Medicinal Products for Human Use (CHMP) meeting highlights. Available at: https://www.ema.europa.eu/en (last accessed December 2020).
4 Popova V, et al. Am J Psych 2019;176:428–438.
5 Fedgchin M, et al. Intl J Neuropsychopharmacol 2019;22(10):616–630.
6 Canuso C, et al. Presented at 58th Annual Meeting of Neuropsychopharmacology (ACNP); December 2019.
