Johnson & Johnson Wins FDA Panel Backing For Nasal Spray Depression Drug; PDUFA Date Awaits

Johnson & Johnson JNJ received encouraging news after a FDA panel decision went its way with respect to its treatment-resistant depression drug.

Panel Finds Risk-Benefit Favorable

A joint committee of the FDA's Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 14-2 against the benefit-risk profile of its Esketamine nasal spray CIII for adults living with treatment-resistant depression. One member abstained from voting.

If approved, the drug could have the distinction of being the first major depression drug approved in decades. The FDA has set a PDUFA action date of March 4 for the pipeline asset.

Esketamine, a drug related to the widely-used party drug Ketamine, has a novel mode of action different from the approved therapies for major depressive disorder, or MDD.

It's a N-methyl-D-aspartate, or NMDA, receptor antagonist, acting by way of restoring synaptic connections in the brain cells of people with treatment-resistant depression.

Multiple Studies Support The Regulatory Application

The panel decision was based on safety and efficacy data from five late-stage studies, three short-term studies, one long-term safety study and one maintenance effect study.

Data from a short-term Phase 3 study and a long-term Phase 3 study showed Esketamine nasal spray and a newly initiated oral depressant provided statistically significant, clinically meaningful, rapid and sustained improvement of depressive symptoms in this difficult-to-treat population

"Our comprehensive research program for esketamine nasal spray supports a positive benefit-risk profile for adults with treatment-resistant depression," said Husseini Manji, Global Head, Neuroscience Therapeutic Area, Janssen R&D.

Vistagen Therapeutics Inc VTGN, which has a similarly acting investigational drug, AV-101, said in its earnings release Tuesday it's continuing to enroll patients in ELEVATE, its Phase 2 study evaluating the efficacy and safety of the asset as an oral adjunctive treatment of patients with MDD, who have an inadequate response to current FDA-approved antidepressants.

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