FDA Just Approved the First Ketamine-Based Fast-Acting Depression Drug

Faith Castro
March 9, 2019

The new drug works differently, targeting a chemical called glutamate that is thought to restore brain connections that help relieve depression. And for people suffering from major depressive disorder for whom nothing else has worked, it may offer a new chance at recovery.

Spravato is said to help with the treatment of depression in adults who have not benefited from at least two other anti-depressant medications. "Also, it seems to work in 24 to 48 hours, so there's a very rapid resolution of symptoms".

According to the FDA, trials of the spray demonstrated a "statistically significant effect compared to placebo on the severity of depression" with some effects noted within two days.

The U.S. Food and Drug Administration approved a new anti-depressant with a chemical similar to ketamine. Compared to many now available antidepressants that may take weeks or months to produce an effect, esketamine works within hours, according to The Washington Post.

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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.

Esketamine is created to be administered intranasally twice a week for an initial 4 weeks, in conjunction with a newly initiated oral antidepressant. But esketamine also seems to have an effect on the opiate system. "We have carefully reviewed the drug, and it met our criteria to get approved for depression treatments". Esketamine and ketamine work by targeting glutamate, unlike now used antidepressants that target serotonin, and doctors were already using ketamine off-label to treat depression, according to the AP. First, the antidepressant will only be available at a physician's office or clinic. According to the FDA, the nasal spray is administered by the patient him or herself while supervised by a medical professional. The patient can leave the health care facility only after the care provider says it's OK (usually about two hours). Patients should not drive or operate heavy machinery until the next day, following a restful sleep.

That means about 5 million of the 16 million people in the USA with major depression might benefit from esketamine, said Courtney Billington, president of Janssen Neuroscience, a unit of Johnson & Johnson.

"We need better treatments for sure", says Dr. Hwang. "I'm now able to appreciate a wider range of emotions than when I was depressed".

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