NHS watchdog rejects use of inhalable antidepressant containing ketamine-like drug
Spravato, made by Covid vaccine maker Janssen, has been rejected for use as an antidepressant on the NHS
A nasal spray treatment for depression derived from ketamine, an illegal party drug, has been rejected for use on the NHS.
Esketamine is said to work by changing brain chemicals responsible for mood, combating feelings of depression within hours.
It is a chemical cousin of ketamine, which itself was first developed as a tranquilizer for horses.
Esketamine is made by Covid vaccine maker Janssen under the brand name Spravato and reportedly costs around £10,000 per course of treatment.
The spray is already approved for use in the US and EU, where doctors say its fast-acting nature can help save lives.
Traditional antidepressants can take weeks to work.
But today the National Institute for Health and Care Excellence (NICE) rejected its use on the NHS as an antidepressant for the third time.
NICE said it was concerned about a lack of evidence that it would ward off depression once a patient stops taking the drug, and that it is too expensive.
Esketamine, a chemical cousin of ketamine, has been used as a party drug since the 2000s. Recent studies on ketamine have also suggested that it might help treat depression.
The watchdog said more research was needed to address these uncertainties.
Mental health charities and the drugmaker said they were deeply disappointed with the decision.
FROM PARTY DRUG TO BIPOLAR TREATMENT: EVERYTHING YOU NEED TO KNOW ABOUT KETAMINE
Ketamine is a powerful general anesthetic used to prevent humans and animals from experiencing pain during operations.
It started being used as a party drug in the late 2000s, with people taking it before raves for a more intense experience.
What are the side effects?
Ketamine causes loss of sensation and paralysis of the muscles.
It can also cause people to experience a distortion of reality, what many call entering the ‘k-hole’.
This is when people believe they have spoken to God or a higher power, which can lead to addiction as they crave that experience.
Ketamine can also make people feel unable to move, experience hallucinations, or cause panic attacks, confusion, and memory loss.
Regular users can severely damage their bladders, so they may need to be surgically removed.
Other risks include elevated heart rate and blood pressure.
Paralysis of the muscles can make people vulnerable to injury, while not feeling pain properly can cause them to underestimate any damage.
Many claim that ketamine withdrawal is worse than any other drug, with some feeling so depressed that they contemplate suicide.
If you have suicidal thoughts, contact the Samaritans. here.
How is it taken and what is the law around it?
For medical use, ketamine is liquid, but the “street” drug is normally a white granular powder, with a gram costing around £20.
As a class B drug in the UK, possession of ketamine can result in people facing up to five years in jail, while supplying it could mean up to 14 years in prison.
Both of these cases can result in individuals facing an unlimited fine.
Source: Talk to Frank
Under the proposal considered by NICE, adults with severe depression who had not responded to at least two different antidepressants would have been offered esketamine.
People would have had to go to the hospital to get the medicine and be supervised by a health professional while taking it.
In its rejection, NICE recognized that there was an unmet need for people with treatment-resistant depression on the NHS.
Around 3 percent of the British population are thought to suffer from depression, with an estimated 6,000 Britons and 48,000 Americans die by suicide each year.
Suicide attempts are believed to be 10 to 20 times higher than these figures.
Amanda Cunnington, Janssen’s senior director of patient access, said they were “deeply disappointed” by the rejection and were considering appealing.
“In treatment-resistant major depressive disorder, there remain systemic problems in introducing innovative treatment options on the NHS, which we have tried to overcome,” he said.
“We remain steadfast in working with stakeholders and are considering all options, including an appeal, to allow access to this important treatment for people living with the condition.”
Marjorie Wallace, chief executive of mental health charity SANE, also said the rejection was a “huge disappointment” and would prevent “desperate” patients from receiving treatment.
“We have little in our arsenal to combat treatment-resistant major depressive disorder and the real shame is that NICE is rejecting one of the few innovations in treating this condition,” he said.
There have been no major pharmaceutical innovations for depression since the launch of Prozac and related antidepressants in the late 1980s.
Those drugs target serotonin, a feel-good brain chemical, and can take weeks or months to kick in.
Instead, esketamine works by targeting a chemical called glutamate that is thought to restore brain wiring, helping relieve depression and can work within four to five hours.
The drug is made from a part of the ketamine molecule, which has been used for decades as a powerful anesthetic to prepare patients for surgery.
Ketamine has also been used illegally as a party drug since the late 2000s and is taken by people before raves, as users may experience a distortion of reality and loss of feeling.
But in February this year, French researchers said it could also ease suicidal thoughts within days.
Doctors tested the therapy on 160 patients who were admitted to hospital due to severe suicidal thoughts.
Nearly two-thirds of the participants who took ketamine no longer had suicidal thoughts after three days. For comparison, the figure was slightly less than a third among patients who received a placebo.
NICE first rejected a submission in January 2020 and then a second time in September of that year.
These rejections were also based on concerns about the cost of treatment.
Current NHS practice to help people with treatment-resistant depression is to provide oral antidepressants and switch to a second medication if symptoms don’t improve. This treatment can also be combined with psychological therapy.
- For confidential assistance, call Samaritans on 116123 or visit a local Samaritans branch, or click here for details