A joint Tuesday meeting of of the Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will issue its verdict on Johnson & Johnson JNJ unit Janssen's NDA for esketamine 28 mg single-use nasal spray.
What is Esketamine
Esketamine, a drug-device combination, is Janssen's investigational, rapidly acting antidepressant that is being evaluated for treatment-resistant depression, or TRD.
The pipeline compound, a N-methyl-D-aspartate, or NMDA, receptor antagonist, acts by way of restoring synaptic connections in the brain cells of people with treatment-resistant depression.
It is related to ketamine, a widely used party drug.
A mixture of esketamine and arketamine is currently approved in the U.S. for inducing and maintaining anesthesia via IV infusion or intramuscular injection.
TRD refers to conditions of patients with major depressive disorder, or MDD, who have not responded to at least two different treatments with antidepressants in a moderate-to-severe depressive episode.
About one-third of the patients with MDD do not experience adequate relief of depressive symptoms after treatment with multiple therapies and are considered to have TRD.
Regulatory Update
Janssen filed a NDA for asketamine in September, with the application supported by five Phase 3 studies: three short-term studies, one withdrawal maintenance of effect study and one long-term safety study.
The FDA granted esketamine nasal spray Breakthrough Therapy Designation, or BTD, for two indications, namely TRD and MDD with imminent risk for suicide.
The PDUFA action date for the TRD indication is March 4.
Subsequently, in October, the company submitted marketing authorization approval, or MAA, to the European Medicines Agency for the nasal spray to treat TRD.
A FDA briefing document released Friday suggested FDA staffers aren't overly concerned over the abuse potential of esketamine given the underlying properties of the compound.
"To mitigate the risk for abuse and misuse of esketamine nasal spray, there will be a comprehensive set of measures in place," the document said.
Those provisions include administration only at the site of care under a health care professional's supervision, product labeling, an extensive educational and training program and resources and device features intended to mitigate abuse and misuse.
Reviewers raised safety concerns, especially regarding a feeling of disassociation that takes roughly 90 minutes to resolve.
Market Potential
Esketamine nasal spray, if approved, could rake in sales of $2.43 billion in 2024 in the U.S. and the five major EU markets, according to Scrip.
Competition
Also in the fray is Allergan plc AGN, which is developing Rapastinel, an intravenous depression drug with a similar mechanism of action as esketamine. Rapastinel also received a breakthrough designation and is in Phase 3 trials.
Vistagen Therapeutics Inc VTGN is evaluating a similar drug codenamed AV-101.
J&J has a lot riding on Esketamine as it continues to seek ways to boost its pipeline, and in turn its top line.
" Our key catalysts for growth include ... securing regulatory approvals for esketamine and erdafitinib, which are two promising new therapeutics with a potential for more than $1 billion of peak revenue," CEO Alex Gorky said during the company's fourth-quarter earnings call.
Tuesday's panel vote is not binding on the FDA, but the agency will consider the panel verdict and deliberations among panel members before it makes a call on esketamine.
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