European Commission authorizes Spravato for rapid reduction of depressive symptoms in MDD

The Janssen Pharmaceutical Companies of Johnson & Johnson have announced European Commission authorization of expanded use of its esketamine nasal spray Spravato among adults with a moderate to severe episode of major depressive disorder.

Specifically, the authorization covers co-administration of the nasal spray with oral antidepressant therapy as acute short-term treatment for the rapid reduction of depressive symptoms.

“Many antidepressants are effective in treating depressive symptomatology but do not provide rapid relief for patients and can take weeks to achieve their full effect,” Maurizio PompiliMD, PhD, director of the University Psychiatric Clinic at Sant'Andrea Hospital in Italy, said in a press release. “The fast-acting nature of esketamine nasal spray in these patients may address a key unmet need within this population.”

The European Commission based its authorization on data from the randomized, placebo-controlled ASPIRE I and II clinical studies, which compared the efficacy and safety of Spravato combined with comprehensive standard of care vs. placebo nasal spray combined with comprehensive standard of care among adults with moderate to severe MDD and current/active suicidal ideation with intent.

Results of these studies showed participants treated with Spravato and comprehensive standard of care exhibited a statistically significant and clinically meaningful reduction in depressive symptoms at 24 hours after administration of first dose vs. placebo nasal spray combined with comprehensive standard of care. Researchers observed benefit of this intervention on MDD symptoms as early as 4 hours after the first dose.

However, Spravato did not demonstrate effectiveness in preventing suicide or in reducing suicidal ideation or behavior. Further, its safety profile among this patient population appeared consistent with prior studies among adults with treatment-resistant MDD. Dizziness, dissociation, nausea, somnolence and headache, respectively, were the most common treatment-emergent adverse events observed during the double-blind phase among the Spravato plus comprehensive standard of care group vs. the placebo nasal spray plus comprehensive standard of care group.

“At Janssen, we are committed to reducing the devastating burden caused by serious mental illnesses and this further authorization of esketamine nasal spray by the European Commission is a key milestone in our ongoing work towards this goal,” Bill Martin, PhD, head of Global Therapeutic Area, Neuroscience, at Janssen Research & Development, said in the release. “Esketamine nasal spray offers adults with MDD who are in need of urgent relief, an effective treatment to reduce their debilitating depressive symptoms. This authorization provides a new and innovative treatment option to this vulnerable population.”