FDA expands approval for Janssen's Spravato nasal spray to cover major depressive disorder with suicidal ideation

The FDA has moved to expand the existing approval of Janssen’s Spravato (esketamine) CIII nasal spray to include treatment of symptoms in major depressive disorder patients who exhibit suicidal behaviour or ideation, when used in combination with oral antidepressant.

Two sets of data supporting the decision showed that Spravato plus standard of care demonstrated reductions of 15.9 and 16.0 on the Montgomery-Åsberg Depression Rating Scale (MADRS) 24 hours following initial dosing, compared to reduction of 12.0 and 12.2 with placebo plus standard of care.

Within 25 days, 41% and 43% of patients receiving Spravato across the two trials achieved clinical remission, showing little to no symptoms, compared to 34% and 27% of patients receiving placebo.

"Many people who live with depression know all too well the feeling of desperation. If that major depression progresses to active suicidal thoughts, it's crushing, and they need options to help change the trajectory of their acute depressive episode," commented Theresa Nguyen, Chief Program Officer at Mental Health America. "Traditional oral antidepressants need weeks or more to take effect, so the availability of a medicine that can begin providing relief within a day is potentially life changing."

However, Spravato has not been proven to prevent suicidal behaviour or ideation, or indeed suicide itself; the difference between Janssen’s therapy and placebo in improvement in severity of suicidality 24 hours after dosing was not found to be statistically significant.  

Matt Fellows