- On Monday, the FDA approved a nasal spray made by Johnson & Johnson shown to ease depressive symptoms within 24 hours.
- The drug – esketamine, a cousin of the “party drug” ketamine – is intended to be used in a clinical setting along with an oral antidepressant and close monitoring.
- Branded as Spravato, the spray works on different parts of the brain than other antidepressants and has been called “the most important discovery in half a century.”
- Spravato can come with serious side effects including dissociation, and hasn’t been shown to be more effective than a placebo or to prevent suicides.
- The timing of the approval, though, is notable as the coronavirus pandemic has exacerbated the nation’s mental health crisis.
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A nasal spray is now available to help people who’ve attempted suicide or are experiencing suicidal thoughts get past their most life-threatening moments.
The drug, esketamine, is a cousin of the anesthetic “party drug” ketamine. It’s made by Johnson & Johnson under the brand name Spravato CII nasal spray.
While Spravato was approved in March 2019 to treat patients with depression who were resistant to other therapies, its new approval allows it to be given to patients at high risk for suicide.
Other antidepressants tend to take several weeks to lift a patient’s mood. Spravato is the first to be shown to work within 24 hours, a press release from The Janssen Pharmaceutical Companies of Johnson & Johnson says.
“That means it can bring some immediate relief to someone while they’re waiting for other treatments to kick in,” Dr. Gerard Sanacora, director of the Yale Depression Research Program and investigator in the drug’s clinical trials, told NPR.
The spray is meant to be used along with other treatments
A person with severe depression can’t simply give themself a spray if they began experiencing suicidal thoughts.
Rather, clinicians can use Spravato for patients who’ve turned up in emergency rooms or psychiatric clinics and are at risk of hurting themselves. (For now, it’s only available in healthcare settings that are part of the drug’s “Risk Evaluation and Mitigation Strategy, or REMS, program.)
It’s meant to be used along with an oral antidepressant and delivered under the direct supervision of a healthcare provider, who closely observes the patient afterwards as well. A full course of treatment is twice weekly for four weeks.
“What we have to be careful of is not to interpret that this as a medication you give once or twice and the person is fine, and you don’t need the follow-up,” Sanacora said.
Close monitoring is also important to manage the drug’s side effects, the most troublesome of which analysts and scientists say is the drug’s tendency to produce “out of body” experiences,Business Insider previously reported. Other side effects include nausea, dizziness, sedation, and increased blood pressure.
But for patients in life-or-death situations, the risks are outweighed by the benefits, the FDA ruled when the drug was first approved.
“I think there’s substantial evidence that this could be a game-changer,” Steven Meisel, a system director of medication safety with Fairview Health Services and a member of FDA’s April 2019 expert panel, said after reviewing the data from Johnson & Johnson’s first five clinical trials.
Esketamine works on a different part of the brain than other antidepressants
Almost all antidepressants work by interfering with neurotransmitters like serotonin and norepinephrine that are involved in mood and emotion.
Spravato is different because it works on the brain’s glutamate system, which is part of the reason it has been called “the most important discovery in half a century” for mental illness, Business Insider previously reported.
Scientists don’t understand yet, though, exactly how it works and why it does so rapidly.
To earn its recent approval, J&J looked at how it worked in depressed patients who were actively contemplating suicide, a population of patients rarely included in drug research.
“It is astonishing to me that despite what we know about the risk of serious suicidal ideation in the context of major depression, patients with suicidal ideation have previously been excluded from nearly all studies examining antidepressant treatment efficacy,” Sanacora said in a press release.
While its study results didn’t show that the drug rapidly reduced the severity of patients’ suicidal thoughts significantly more than a placebo, it was approved due to its safety and to give clinicians another option in urgent situations.
It has not been proven to prevent suicides.
The coronavirus pandemic has heightened the need for mental illness treatments
Prior to the coronavirus pandemic, the US was grappling with a suicide crisis, with the rate rising 35% from 1999 to 2018. According to Centres for Disease Control and Prevention statistics, it’s already the 10th-leading cause of death.
Now, with more limited access to mental health treatments, increased social isolation, derailed routines, and lost lives and jobs, experts have warned of an impending suicide epidemic alongside the public health emergency.
Healthcare workers seem to be especially at risk. In New York City alone, a physician and EMT died by suicide within days of each other.
Dr. Wendy Dean, a psychiatrist, wrote in STAT that while the US was unprepared for the coronavirus pandemic, it must be prepared for the corresponding mental health crisis.
“Failing to prepare properly for the mental health aftermath of the pandemic would be another structural betrayal of frontline health care workers, exposing them to needless suffering and possibly death,” she wrote. “We must choose to be ready.”
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