The US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for esketamine (Spravato) CIII nasal spray, clearing the way for its use as a treatment for depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior, in conjunction with an oral antidepressant.
Esketamine was approved by the FDA on March 5, 2019, as a treatment for treatment-resistant depression, also when taken with an oral antidepressant.
The sNDA approval is based on two Phase 3 clinical trials in which the nasal spray plus comprehensive standard of care demonstrated a significant, rapid reduction of depressive symptoms within 24 hours, with some patients starting to respond in as little as 4 hours, according to a statement from Janssen Pharmaceutical Companies of Johnson & Johnson.
“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,” said Theresa Nguyen, chief program officer, Mental Health America.
A full treatment course for the new indication is twice a week for 4 weeks, after which future treatment plans should be evaluated.
“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,” said investigator Gerard Sanacora, PhD, MD, director, Yale Depression Research Program, New Haven, Connecticut.
Esketamine carries a Boxed Warning on a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behaviors. Healthcare providers must be certified before they can administer the medication.
Janssen announces U.S. FDA approval of Spravato® (esketamine) CIII nasal spray to treat depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior [press release]. Titusville, NJ: Janssen Pharmaceutical Companies of Johnson & Johnson; August 3, 2020.