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Johnson&Johnson’s anti-depressant spray reduces symptoms in day
Johnson and Johnson’s SPRAVATO® is the first and only approved medicine that has been shown to reduce depressive symptoms within 24 hours.
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation orbehavior.
SPRAVATO provides a new option for significant symptom relief until a longer-term, comprehensive treatment plan can take effect.
The effectiveness of SPRAVATO® in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated.
Use of SPRAVATO® does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO®.
SPRAVATO® carries a Boxed Warning regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behaviors.
Depression is the leading cause of disability worldwide and the condition most frequently associated with suicide.
“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,” said Theresa Nguyen, Chief Program Officer, 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.”
The sNDA approval is based on two identical Phase 3 clinical trials in which SPRAVATO® plus comprehensive standard of care demonstrated a significant, rapid reduction of depressive symptoms within 24 hours, with some patients starting to respond as early as four hours.
“It is astonishing to me that despite what we know about the risk of serious suicidal ideation in the context of major depression, patients with suicidal ideation have previously been excluded from nearly all studies examining antidepressant treatment efficacy. There is an immense need for high quality evidence showing effective and rapid antidepressant action in this population,” said Gerard Sanacora,* Ph.D., M.D., Director, Yale Depression Research Program, Co-Director, Yale New Haven Hospital Interventional Psychiatry Service, and esketamine clinical trial investigator. “The clinical trials supporting this new indication provide compelling evidence that esketamine may offer clinicians a new way to provide support to patients quickly in the midst of an urgent depressive episode and help set them on the path to remission.”
In the two Phase 3 trials, improvement in the severity of suicidality at 24 hours was measured using a standardized global scale.
“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, LLC. “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.”