FDA approves Johnson & Johnson’s ketamine-derived nasal spray for depression as standalone treatment
Major depressive disorder affects an estimated 8.3% of the adult population. And now there’s a new option for treatment: Spravato, a nasal spray that’s been shown to give rapid relief to depression symptoms, just approved as a standalone therapy by the Food and Drug Administration.
"Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them,” Bill Martin, neuroscience leader with the drug’s manufacturer, Johnson & Johnson, said in a news release. “For too long, healthcare providers have had few options to offer patients much-needed symptom improvement."
Oral antidepressants, developed in the 1950s and currently one of the most frequently prescribed medications in the U.S., fall into several classes; they include selective serotonin reuptake inhibitors (SSRIs), the most common type (such as Lexapro and Prozac), and serotonin and norepinephrine reuptake inhibitors (SNRI's), such as Effexor and Cymbalta. But in addition to some people not responding to such treatments, they are also extremely difficult to wean off of, as they can cause withdrawal and relapse, prompting some people to search for alternatives.
Spravato is made from esketamine, which is derived from ketamine—a schedule-III drug that’s FDA-approved as an anesthetic (and often abused) but has shown promise as an off-label IV treatment for depression in clinical settings.
The nasal spray was first approved by the FDA in 2019 as a supplemental treatment, along with an oral medication, for the approximately one-third of people with MDD who struggle with treatment-resistant depression (meaning they did not respond to two oral medications). But now, following a large study that found Spravato alone worked better than a placebo, it can be prescribed as a monotherapy.
It works by targeting glutamate—the most abundant excitatory neurotransmitter in the brain—although the mechanism by which esketamine works as an antidepressant effect is not known, says Johnson & Johnson.
According to the news release, patients can expect to see improvements in depressive symptoms in 28 days—and maybe as quickly as 24 hours—without also relying on daily antidepressant pills.
Still, it will only be administered in healthcare settings because of the possibility of serious side effects, including: sleepiness (sedation); fainting; dizziness; dissociation (spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, or space and time); and breathing problems (including respiratory arrest).
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This story was originally featured on Fortune.com
