FDA/CDC

FDA panels back intranasal esketamine for refractory depression

Publish date: February 12, 2019
By
Michele G. Sullivan

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‘An important day for psychiatry’

“The REMS program that was proposed by the company and seemingly endorsed by the FDA provides adequate protection,” Sanjay J. Mathew, MD, said in an interview. “I think that was one of the reasons it sailed through the panels.”

An important aspect of intranasal ketamine is that, as an N-methyl-D-aspartate receptor antagonist, it is “an entirely new class” for treating depression, said Dr. Mathew. “This is the first approval that does not work on serotonin or norepinephrine or dopamine. This is a big, big development. We can’t overstate that.”

Also, the nasal spray had to beat a placebo and a newly administered antidepressant. “There was a relatively high bar for showing convincing efficacy,” he said. “So if approved, this drug would be prescribed with an oral antidepressant. Intranasal esketamine represents 20 years’ worth of effort. Today was an important day for psychiatry,” he said. “It was an important day for patients with depression.”

Dr. Mathew is the Marjorie Bintliff Johnson and Raleigh White Johnson Jr. Vice Chair for Research and professor in the Menninger department of psychiatry & behavioral sciences at the Baylor College of Medicine in Houston. He has served as a consultant for and has had research funded by Janssen.


 

ROCKVILLE, MD – If approved for treatment-resistant depression, intranasal esketamine will be strictly regulated in the clinic, with federal monitoring requirements designed to prevent misuse, abuse, or diversion of the drug.

FDA icon Wikimedia Commons/FitzColinGerald/Creative Commons License

Managed under a Food and Drug Administration Risk Evaluation and Mitigation Strategy (REMS), such a program would establish a stringent post-administration protocol of observation and blood pressure monitoring and require every provider – whether a large health care center or a single clinician – to obtain federal certification to dispense the medication.

At a joint meeting of FDA’s Psychopharmacologic Drugs Advisory and Drug Safety and Risk Management Advisory committees, some members offered a more tempered view while still supporting the approval pathway of the N-methyl-D-aspartate receptor antagonist. By a vote of 14-2, with one abstention, they agreed Feb. 12 that the benefits outweigh the risks of esketamine for treatment-resistant depression.

“I think it has the potential to be a game changer in treatment-resistant depression,” said Walter Dunn, MD, PhD, of the University of California, Los Angeles. “We may someday talk about 2019 in the same way we now talk about the late ’80s, when the first [selective serotonin reuptake inhibitors] were approved.”


Janssen Pharmaceuticals, which is developing the drug, incorporated concerns about misuse from the beginning. Even the delivery device is designed to prevent such issues, a company spokesman said.

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