An antidepressant nasal spray derived from the illegal ‘party’ drug ketamine has been approved by US health chiefs to treat suicidal people (stock picture)
An antidepressant nasal spray derived from the party drug ketamine has been approved by US health chiefs to treat suicidal people.
Spravato — made by American pharmaceutical and consumer giant Johnson and Johnson — was last night given the green light by the Food and Drug Administration (FDA).
The decision means doctors across America will now be able to dish out the treatment to patients with suicidal thoughts who have failed to find relief with other antidepressants.
The spray could be a lifesaver for the estimated 2million people in the US who suffer suicidal thoughts, because traditional antidepressants can take weeks to kick in.
Clinical studies have shown Spravato – which exceeds $1,000 for the average course – can dramatically reduce major depression in just four hours.
The fast-acting spray is made from esketamine, a chemical cousin of the ketamine, which which has been used for decades as a powerful anesthetic to prepare patients for surgery.
In the 1990s, the medication was adopted as a party drug by the underground rave culture due to its ability to produce psychedelic, out-of-body experiences. More recently, some doctors have given ketamine to people with depression without formal FDA approval.
It comes as the US grapples with a suicide crisis that has seen rates increase by more than a third in the last two decades. Nearly 50,000 Americans now take their own lives each year.
Back in 2006, evidence emerged that ketamine might improve symptoms of depression in some patients (file image)
There is growing fear that more Americans will plunge into depression in the wake of Covid-19 and the economic fallout that proceeds it.
Spravato was approved after passing two phase 3 clinical trials which showed a significant and rapid reduction in depressive symptoms within 24 hours. Previous studies have shown its effects start to kick in between four and five hours.
Forty-two per cent of those treated with the nasal spray were cured of their depression within a month, compared with 30 per cent in the placebo group.
Michelle Kramer, vice president of Johnson & Johnson’s US neuroscience medical affairs unit, said: ‘Relatively rapidly within a few weeks we saw the numbers stabilise, which was pretty interesting for us and validating in the sense that clinics and patients alike were continuing to make this available.
‘We certainly see more and more sites sign on and more and more patients are treated.’
There have been no major pharmaceutical innovations for depression since the launch of Prozac and related antidepressants in the late 1980s.
Those drugs target the feel-good brain chemical serotonin, and can take weeks or months to kick in.
Ketamine and J&J’s version work differently than those drugs, targeting a chemical called glutamate that is thought to restore brain connections that help relieve depression.
When the drug works, its effect is almost immediate. 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. If the drug doesn’t work, physicians can quickly switch to other options, he noted.
The drug is designed to be lower-dose and easier to use than ketamine, which is normally given as an intravenous infusion.
America has been struggling to prevent suicide rates from increasing since before the coronavirus pandemic, with the rate rising 30 per cent from 1999 to 2016.
In 2017, the U.S. suicide rate rose to 14 deaths per 100,000 people, the highest rate in at least 50 years, according to federal records.
Government officials haven’t suggested an explanation for the trend, though academic researchers point to the nation’s widening income gap, financial struggles and divisive politics.
J&J’s drug will be subject to a number of restrictions due to its abuse potential, side effects and lingering safety questions.
The drug will only be given by accredited specialists who must monitor patients for at least two hours after administration, due to its trippy, disorienting effects. Additionally, all patients will be tracked in a registry to monitor long-term safety and effectiveness.
The immediate impact of ketamine is thought to last just four to seven days and there’s no consensus yet on how long patients can benefit from ongoing treatment.
Still, there are few other options for patients who fail to respond to antidepressants.
The most effective treatment in such cases, electroshock therapy, requires patients to be fully sedated and can cause persistent memory loss.
A decades-old drug, ketamine is already used off-label to treat depression by some doctors. At least 150 clinics around the U.S. provide treatment with various forms of the drug, which is available as a low-cost generic.
Patients often pay hundreds or thousands of dollars for intravenous infusions of the drug over several weeks or months. Such therapies are generally not covered by insurance because they haven’t been approved as safe and effective by FDA regulators.