FDA Expected To Approve Esketamine Nasal Spray For Depression

Mar 4, 2019
Originally published on March 7, 2019 7:03 am

The Food and Drug Administration is expected to approve a new type of drug for depression. It is esketamine, a chemical cousin of the anesthetic and party drug ketamine.

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The Food and Drug Administration is about to approve a nasal spray that can relieve severe depression in hours instead of weeks. The drug is based on the anesthetic ketamine, which is also a mind-altering party drug. And as NPR's Jon Hamilton reports, it represents the first truly new drug for depression in decades.

JON HAMILTON, BYLINE: The drug is called esketamine, and it works through a different mechanism than antidepressants like Prozac, which have been around since the 1980s. In early February, advisers to the FDA recommended approving esketamine. The agency is expected to follow their advice any day now.

Dr. Dennis Charney is dean of the Icahn School of Medicine at Mount Sinai in New York. He says esketamine's means approval would be a big deal.

DENNIS CHARNEY: This is potentially a game-changer for millions of people.

HAMILTON: Charney says esketamine works quickly and can help patients with major depressive disorder who haven't improved on other drugs.

CHARNEY: Many of them are suicidal, so it's essentially a deadly disease when you haven't responded to available treatments and you've been suffering for years, if not decades.

HAMILTON: Charney holds patents associated with both ketamine and esketamine. He also helped conduct the first studies, done two decades ago, showing that ketamine could treat depression. Charney says esketamine's imminent approval shows that this early work was on the right track.

CHARNEY: For me, it's very gratifying. And I think the key word for patients is hope.

HAMILTON: But esketamine presents some challenges because of its similarities to ketamine. In high doses, both drugs can cause sedation and out-of-body experiences. And ketamine, often called Special K in its illicit form, has become a popular party drug. So Johnson & Johnson, the company that developed esketamine, has promised to make sure it will be used only as intended.

Courtney Billington is president of Janssen Neuroscience, a part of Johnson & Johnson. He says esketamine, if approved, will be marketed under the brand name Spravato.

COURTNEY BILLINGTON: Spravato will not be dispensed directly to a patient to take it home. It will only be available in approved and certified treatment centers.

HAMILTON: Billington says esketamine will be limited to patients who have tried at least two other anti-depressants. They'll visit a treatment center once or twice a week to inhale the drug under supervision. And Billington says hallucinogenic experiences are unlikely.

BILLINGTON: The amount of active ingredient that's in this product is at a very, very low dose.

HAMILTON: The FDA's decision on esketamine comes as more and more doctors have begun administering a generic version of ketamine for depression. The generic is approved only as an anesthetic, but doctors can legally prescribe it for other medical uses. Dr. Demitri Papolos, director of research for the Juvenile Bipolar Research Foundation, prescribes ketamine for a disorder that includes symptoms of depression. He predicts that doctors already comfortable with ketamine will continue to offer the treatment.

DEMITRI PAPOLOS: I certainly hope so because it'll be a lot less expensive and a lot easier for their patients.

HAMILTON: Papolos says the generic form is cheap and can be taken at home in a nasal spray once patients know the right dose. Papolos also says recent animal studies suggest that esketamine may be less potent than its older sibling.

PAPALOS: It may not be as effective as what is a generic, but any psychiatrist or physician can prescribe without the restrictions that are going to be applied to esketamine.

HAMILTON: Generic ketamine costs only a few dollars a dose. It's not clear yet how much esketamine will cost. Jon Hamilton, NPR News. Transcript provided by NPR, Copyright NPR.