Spravato Receives New Indication to Treat Depression

August 3, 2020 – The U.S. FDA has approved a new indication for Spravato® (esketamine) nasal spray, manufactured by Janssen Pharmaceuticals. Spravato is now indicated for use in conjunction with an oral antidepressant to treat depressive symptoms in adults who have major depressive disorder (MDD) with acute suicidal ideation or behavior.

Depression is a leading cause of disability in the United States and one of the most common mental health disorders. To be diagnosed with MDD, which is also known as clinical depression, a patient must experience persistent symptoms for at least two weeks. These can include but aren’t limited to feelings of hopelessness, loss of enjoyment, physical aches and pains, fatigue, restlessness, inability to sleep and/or sleeping excessively, changes in appetite and weight, and thoughts and/or acts of self-harm, including suicidal ideation and behavior. Depression can be difficult to treat, with many patients trying multiple medications and medication combinations over the course of several months before experiencing relief from symptoms.

In clinical trials, Spravato plus comprehensive standard of care delivered a significant reduction of symptoms within 24 hours, making Spravato the only FDA-approved medication proven to reduce depressive symptoms within a day. Some patients in the study responded to treatment as early as four hours. The comprehensive standard of care included initial hospitalization, a newly initiated or optimized oral antidepressant, and twice-weekly treatment visits for four weeks.

Recommended dosing under the new indication is 84mg twice weekly for four weeks, administered as a nasal spray by or under the direct supervision of a healthcare professional. The dose can be reduced to 56mg twice a week based on tolerability. After four weeks of treatment, evidence of therapeutic benefit should be evaluated to determine if there is a need to continue Spravato. The use of Spravato in conjunction with an oral antidepressant beyond four weeks has not been systematically evaluated in the treatment of depressive symptoms in patients who have MDD with acute suicidal ideation or behavior. In addition, the effectiveness of Spravato in preventing suicide or reducing suicidal ideation or behavior has not been demonstrated.

A black box warning cautions that there is a risk of sedation, dissociation, and abuse and misuse of Spravato. There is also a black box warning that antidepressants can increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients. Spravato is a Schedule III controlled substance, and only available under a Risk Evaluation and Mitigation Strategy (REMS) program. It is not intended for use outside of a clinical setting.

The FDA first approved Spravato in 2019 for use in conjunction with an oral antidepressant to treat adults who have treatment-resistant depression.