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.

Related Links:

Gilead's Failed NASH Drug Trial Drags Stock Lower

The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trials

Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: Long IdeasNewsHealth CareFDATop StoriesTrading IdeasGeneraldepressionEsketamineHusseini ManjiKetamine
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!