NEW BRUNSWICK (dpa-AFX) - 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.



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