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FDA approves ketamine-like nasal spray for depression

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The US Food and Drug Administration approved Janssen Pharmaceuticals Inc.'s ketamine 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.

Axar.az reports citing CNN.

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.

Side effects of Spravato include dizziness, nausea, vertigo, anxiety, lethargy, increased blood pressure, vomiting, feeling drunk, decreased sensitivity, sedation and dissociation, a feeling of being temporarily "disconnected" from your body and your mind.

The drug label will contain a "boxed warning" to alert patients to the risk of "sedation, and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviours after administration of the drug," the agency said in its announcement.

Because of these risks, patients must be monitored for at least two hours after being given the drug.

Date
2019.03.06 / 17:06
Author
Axar.az
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