Ketamine-based drug approved for treating severe depression in US

'I just let the drug work. I close my eyes and my mind is amazingly quiet'

Alex Matthews-King
Health Correspondent
Thursday 07 March 2019 11:00 GMT
Ketamine-based drug approved for treating severe depression in US

A breakthrough treatment based on the recreational drug ketamine has been approved in the US for people with severe depression.

Esketamine is administered as a nasal spray and was approved by the Food and Drug Administration (FDA) this week after trials showing it could relieve depressive symptoms within hours.

This is unlike regular antidepressants, which can take weeks to work leaving sufferers, who may be contemplating suicide, incredibly vulnerable.

“[That speed] is a huge thing because depressed patients are very disabled and suffer enormously,” said Dr John Mann, a psychiatrist and researcher at Columbia University.

Esketamine is the first approved depression treatment for more than 30 years to act on the brain in a unique way, and will be offered to patients who have tried at least two other treatments without success.

Because of the potential for abuse, esketamine is administered under medical supervision, with patients supervised for two hours afterwards.

“You can feel it coming on, it’s a strong drug,” Robin Prothro, 60, says, describing colours and shapes that drift before her eyes. “I just let the drug work. I close my eyes and my mind is amazingly quiet.”

Because the drug’s effects last much longer than conventional antidepressants, she only needs to attend once every two weeks.

Ms Prothro has been on antidepressants for more than 20 years and enrolled on the Spravato trial as the five different medications she tried previously were ineffective.

Since joining the trial she has been able to return to hobbies which she abandoned years ago, like gardening.

The esketamine molecule is a mirror image of the ketamine molecule – which has a long history of use in medicine as an anaesthetic – but is three times as potent, meaning it can be given at a lower dose.

In the UK some NHS groups offer ketamine-assisted treatment for major depression – but this has to be given as an intravenous infusion, which is more labour intensive than the spray.

It works by targeting glutamate receptors in the brain and promoting new connections between brain cells. However, some groups have warned it acts in a similar way to opioid painkillers which are driving an addiction epidemic in the states.

The drug was developed by Janssen – part of Johnson and Johnson – and is being marketed under the name Spravato.

“There has been a longstanding need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Dr Tiffany Farchione, acting director of the Division of Psychiatry Products at the FDA.

“Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment.”

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