J&J submits supplemental new drug application for SPRAVATO Nasal Spray

USA—Johnson & Johnson has filed a supplemental New Drug Application (sNDA) with the United States Food and Drug Administration (FDA) seeking clearance for SPRAVATO (esketamine) CIII nasal spray as a monotherapy.

SPRAVATO is a prescription medication used in conjunction with an oral antidepressant to treat people with treatment-resistant depression (TRD) and depressive symptoms in adults with major depressive disorder (MDD) who have suicidal thoughts or behaviors.

This submission is supported by positive results from the Phase 4 TRD4005 study, which evaluated the efficacy, safety, and tolerability of SPRAVATO when administered as a standalone treatment.

The randomized, double-blind, multicenter, placebo-controlled study demonstrated a rapid change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score as early as 24 hours after the first dose of SPRAVATO, with these effects sustained through at least four weeks of treatment.

Remarkably, the safety profile of SPRAVATO as a monotherapy was consistent with the existing body of clinical data when used in combination with an oral antidepressant, with no new safety concerns identified.

Bill Martin, PhD, Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine, commented on the medicine, stating that many patients suffering from difficult-to-treat depression spend far too much time cycling through several treatments that do not adequately relieve their symptoms.

 This extended search for successful treatment can place a tremendous functional and emotional strain on both patients and their loved ones.

 Dr. Martin emphasized his willingness to expand on more than a decade of studies confirming SPRAVATO’s safety and efficacy.

He looks forward to collaborating with the FDA to deliver this unique medicine to patients as a monotherapy option.

The FDA has already approved SPRAVATO in combination with an oral antidepressant to treat adults with TRD and depressive symptoms in adults with MDD who exhibit acute suicidal ideation or behavior.

Over 30% of the estimated 280 million people worldwide who suffer from major depressive disorder (MDD) have TRD, which happens when two or more oral antidepressants fail to work during the same depression episode.

So far, SPRAVATO has been approved in 77 countries and administered to over 100,000 people throughout the world.

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