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FDA approves ketamine-like nasal spray for depression

03/07/2019

(CNN) – The US Food and Drug Administration approved Janssen Pharmaceuticals Inc.’s esketamine on Tuesday for treatment-resistant depression; the drug is the chemical cousin of ketamine, the powerful anesthetic that has been used illegally as the club drug Special K.

It will be sold as Spravato. More specifically, it’s for patients who have tried at least two other medications without success, and it should be taken with an oral antidepressant.

“There has been a longstanding need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products at the FDA’s Center for Drug Evaluation and Research, said in a news release announcing the approval.

Spravato is a nasal spray administered by an approved health care provider in a doctor’s office or a medical clinic. It may also be self-administered but only under the supervision of a care provider and cannot be taken home.

“Because of [safety] concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient,” Farchione said

Depending on the severity of the patient’s depression, it is given either once a week or once every other week.

The drug is rapidly acting, so it starts working faster than other antidepressants, according to Janssen. It works by restoring brain cells in patients with treatment-resistant depression.

Currently available treatments for major depression are ineffective in 30% to 40% of patients. According to the FDA, there is one other approved medication for treatment-resistant depression, Symbyax, which was approved in 2009.

Read the full story at cnn.com


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