Johnson & Johnson Seeks FDA Approval For SPRAVATO Nasal Spray For Treatment-Resistant Depression

(RTTNews) - Johnson & Johnson (JNJ) announced the submission of a supplemental New Drug Application or sNDA to the U.S. Food and Drug Administration seeking approval of SPRAVATO (esketamine) CIII nasal spray as a monotherapy for adults living with treatment-resistant depression or TRD.

The submission is supported by positive results from the Phase 4 TRD4005 study that evaluated the efficacy, safety and tolerability of SPRAVATO® administered as a monotherapy. The Phase 4 data showed rapid improvement in depressive symptoms at about 24 hours, sustained through at least 4 weeks.

Nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder or MDD have treatment-resistant depression or TRD, which occurs when there is an inadequate response to two or more oral antidepressants during the same depressive episode.

SPRAVATO is approved by the FDA, in combination with an oral antidepressant, to treat adults with TRD and depressive symptoms in adults with MDD with acute suicidal ideation or behavior. To date, SPRAVATO has been approved in 77 countries and administered to more than 100,000 people worldwide.