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US regulatory body approves nasal spray for ‘chemical cousin’ of ketamine to treat people with depression



March 07, 2019 13:24:34

A Sydney psychiatrist says the approval of a ketamine-like nasal spray for use as a treatment for severe depression in the US presents a “tremendous opportunity” for Australia.

Key points:

  • The drug is administered as a nasal spray and patients must be monitored for two hours
  • Esketamine works on different receptor systems than current anti-depression medication, and is believed to help rejuvenate braincells
  • Some trial patients reported a range of side effects, and long-term effects are not known

Esketamine, the drug in Janssen Pharmaceuticals’ Spravato nasal spray, has been described as a “chemical cousin” to ketamine, also known as special K.

Ketamine has been used as a powerful anaesthetic to prepare patients for surgery, but was misused as a party drug in the 1990s due to its ability to produce psychedelic sensations.

On Tuesday, the US Food and Drug Administration (FDA) approved Spravato for use as a treatment for patients who have failed to find relief from depression with at least two antidepressants.

The approval was granted on the basis of it being used in conjunction with an oral antidepressant.

University of Sydney’s Brain and Mind Centre co-director Ian Hickie pointed out the drug had been used in emergency departments to provide fast-acting treatment to acutely depressed, suicidal patients.

He says this new drug was a “tremendous opportunity” to treat severe depression in Australia, but one the government needs to handle strategically.

“We need to get into this early, but do it smart,” Professor Hickie said.

“Historically, we get into it late and do it dumb.

“Waiting five more years — that’s the dumb approach.

“We think restricting entry will help — we hope that by delaying it, they’ll figure out the problems in the US first.

“That’s not the case.”

How does ketamine work?

UNSW psychiatrist Colleen Loo has been studying the use of ketamine as a treatment for depression for six years, and is currently in the midst of trialling the drug in a study with the Black Dog Institute.

“It works on different receptor systems in the brain than the currently known anti-depression medications,” she explains.

“We think that’s why it seems to work when other things haven’t worked.”

The effects can be almost immediate.

While it can take weeks to see in improvement with other medications, ketamine can work within hours.

Professor Loo said that like many medications, it is difficult to pinpoint exactly what ketamine does that makes it effective.

However, it’s thought the drug helps to rejuvenate braincells which can be impacted by chronic depression.

“It has a strong effect in regrowing and plumping nerve cells,” she said.

‘You can feel it coming on’

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

Robin Prothro, 60, had tried five medications to treat her depression before taking part in the trial.

She claims the drug has helped her come back to hobbies she abandoned years ago, such as gardening.

Ms Prothro, who takes the drug every two weeks at her psychiatrist’s office, says her depression has lifted since participating in the trial.

“You can feel it coming on, it’s a strong drug,” she said, 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.”

Addressing safety concerns

But the drug is not without its downsides.

Some of the patients treated with Spravato in the clinical trials experienced disassociation, dizziness, anxiety, lethargy, increased blood pressure, vomiting and feeling drunk, among other side effects.

Acting director of the FDA’s Division of Psychiatry Products Tiffany Farchione said the approval process included “a robust discussion” about safety issues surrounding the product.

“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 healthcare provider can monitor the patient,” she said.

The approval stipulates that patients must be monitored for two hours after receiving a dose.

Patients will also have to make arrangements to ensure they leave the health facility safely and will be advised not to drive for the rest of that day.

Immediate side effects aside, Professor Loo said there were still unanswered questions about the drug.

Her study is still recruiting participants, meaning there is a long way to go until the results are known.

She has seen some “very promising” results, but she said every patient was different and therefore have different experiences with the drug.

She said some patients, which she called “super responders”, experience dramatic improvements that are sustained for a month, however others relapse.

“The big question is, how long do you stay well after that — one month? Six months?” Professor Loo said.

“You can’t be taking it for the rest of your life — nobody knows the safety implications of doing that.”

That’s why Professor Loo supports the stipulation of the drug being used in conjunction with an ongoing antidepressant in the context of a continuous treatment plan with professionals.

Close monitoring needed for Australia

Both Professor Loo and Professor Hickie are in favour of the drug being used in Australia, but want extensive monitoring systems put in place to help answer questions about ongoing treatment and long-term effects of ketamine use.

“Many of these questions you cannot answer by simply saying ‘do more trials’,” Professor Hickie said.

“It needs to be in the post-marketing phase.”

He’d like to see surveillance put in place to track how effective the treatment is, perhaps in the form of a licencing requirement that forces manufactures to monitor patients.

“Our ad hoc monitoring or reporting with GPs is a hopelessly inadequate system,” Professor Hickie said.

“I’d like to see companies working with the government with a clinical framework to make sure short and long-term monitoring takes place.

“What happens next really matters.”









First posted

March 06, 2019 21:51:12

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