FDA approves ketamine-like nasal spray for depression

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WASHINGTON (AP) — A mind-altering medication related to the club drug Special K won U.S. approval Tuesday for patients with hard-to-treat depression, the first in a series of long-overlooked substances being reconsidered for severe forms of mental illness.

Dr. Fadi Tayim, Director of CNSI Brain Mapping Center at Premier Health, joined 2 NEWS Wednesday to disuss the medication.

The nasal spray from Johnson & Johnson is a chemical cousin of ketamine, which has been used for decades as a powerful anesthetic to prepare patients for surgery. In the 1990s, the medication was adopted as a party drug by the underground rave culture due to its ability to produce psychedelic, out-of-body experiences. More recently, some doctors have given ketamine to people with depression without formal FDA approval.

The Food and Drug Administration approved Spravato as a fast-acting treatment for patients who have failed to find relief with at least two antidepressants. Up to 7.4 million American adults suffer from so-called treatment-resistant depression, which heightens the risk of suicide, hospitalization and other serious harm, according to the FDA.

“This is the first time in history that an anti-depressant drug will be operating on a different mechanism, which is something that’s been necessary for at least 30 years,” Dr. Tayim says.

The drug will cost between $590 and $885 depending on the dosage and before various insurance discounts and rebates.

There have been no major pharmaceutical innovations for depression since the launch of Prozac and related antidepressants in the late 1980s. Those drugs target the feel-good brain chemical serotonin, and can take weeks or months to kick in.

Ketamine and J&J’s version work differently than those drugs, targeting a chemical called glutamate that is thought to restore brain connections that help relieve depression.

The FDA approved Spravato, known chemically as esketamine, based on study results that showed patients taking the drug experienced a bigger improvement in their depression levels than patients taking a sham treatment, when measured with a psychiatric questionnaire.

“In this case, esketamine, since this is an inhalant form, it can alleviate peoples’ depression symptoms within a matter of minutes rather than weeks or months that it typically takes other anti-depressants,” Dr. Tayim says.

The drug is designed to be lower-dose and easier to use than ketamine, which is normally given as an intravenous infusion.

Dr. Tayim adds that this nasal spray is only available at a doctor’s office.

“There are side effects with hallucinations that may be reported given the mechanism of action of ketamine, so we want to make sure that everything is always safe and observed,” he said.

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