The U.S. Food and Drug Administration has approved the first new kind of depression treatment seen in decades, a nasal spray drug based on the sedative ketamine.
The new drug, licensed by Johnson & Johnson’s pharma division, Janssen Pharmaceuticals, isn’t ketamine exactly. It’s derived from esketamine, a chemical sibling of ketamine. It will be sold under the brand name Spravato.
For years, ketamine has been prescribed off-label via IV infusion for people struggling with severe depression and suicidal ideation, with some patients experiencing relief within hours. Importantly, these are typically patients who haven’t responded well to other treatments. The nasal spray will be approved for this same select group of patients.
“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in an FDA statement. “Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment.”
According to the FDA, J&J’s esketamine will be approved for people with treatment-resistant depression, meaning people who haven’t responded to at least two other antidepressant drugs. The drug will need to be taken alongside a standard antidepressant, and each dose will be administered under close medical supervision, with patients being monitored for at least two hours before being allowed to leave the clinic.
Dennis Charney, dean of the Icahn School of Medicine at Mount Sinai, was one of the first scientists to investigate and find evidence of ketamine’s benefits in treating depression and suicidal ideation; he later became one of the co-inventors of the nasal spray. (Charney, Mount Sinai, and others hold patent rights over the drug, which have since been licensed to J&J). Charney told Gizmodo that Spravato will give people who previously couldn’t afford the out-of-pocket costs of ketamine a new option for treatment.
“I’m obviously biased here, but this is honestly a game changer for depression treatment,” Charney told Gizmodo, echoing a familiar refrain shared by many in the field. “I mean, we’re talking about potentially millions of people who might be able to benefit from this treatment, if they haven’t responded to others.”
Because insurance companies typically don’t cover ketamine when used as an antidepressant, patients have been forced to pay hundreds of dollars per infusion out-of-pocket (the number of needed total infusions can vary, depending on the patient and their response, but it’s often half a dozen or more per each treatment course). J&J did not yet respond to a request for comment from Gizmodo concerning the pricing of Spravato.
The FDA’s decision comes in the wake of a nearly unanimous vote by an advisory committee to approve the drug last month. While the majority of experts agreed the benefits of ketamine outweighed any potential risks, short-lasting side-effects such as disorientation, raised blood pressure, and headaches have been commonly found. These same experts, even those who gave the drug their approval, also pointed out the lack of research into its long-term risks as a depression treatment, such as patients developing a substance use disorder or even brain damage—both of which have been seen in recreational users. And they called for long-term research to keep track of new ketamine patients and look out for these risks.
Charney, who said he wasn’t involved in J&J’s clinical development of Spravato, believes it’s important to keep a wary eye on the risks of ketamine. But he noted that ketamine dosages typically given to depression patients are often several-fold smaller than what people take recreationally.
“It’s something we’ve been able to look at for a couple years now. And I and the clinicians I’ve talked to, we haven’t seen that with patients,” he said. “At least so far, the risk of abuse seems to be very low.”