Silver Spring, MD — An expert panel that advises U.S. federal regulatory authorities has recommended approval of Esketamine, Johnson & Johnson’s brand-new treatment for depression. Powered by the active ingredients of ketamine, a hallucinogenic club drug in vogue around the end of the last century, Esketamine is set to be the first new treatment for depression in years. It’s nearly certain that the F.D.A. will officially greenlight the drug very soon.
Recently, ketamine has been administered via intravenous infusion—only at certain clinics and always off-label, the time-intensive therapy usually costs around $3,000. Part of its allure is that, though typical depressions treatments take weeks to kick in, patients who have received intravenous ketamine report experiencing relief within hours. Perhaps most important, Esketamine boasts an easy mechanism of delivery: it’s a nasal spray. On top of that, it would be covered by most insurance plans.
Most go-to antidepressants work by modifying a person’s levels of serotonin, the neurotransmitter associated with feelings of wellbeing. (It plays critical roles in many other cognitive processes too.) Esketamine does not affect serotonin levels; in fact, the discovery of its effect on depression was serendipitous. Researchers hope that Esketamine’s efficacy will shed some light on the biology of depression, which remains, in no small part, a mystery.
Dr. James Murrough, a psychiatrist at Manhattan’s Mt. Sinai Hospital, believes that approval of Esketamine would represent a watershed moment in medical history. “I’m still a little bit in shock,” he says. “If this comes to pass, we’ll have done what people have been quick to point out hasn’t been done since the original discovery of antidepressants.”
The drug’s two greatest risks are potential for abuse and hallucinations. Steven Meisel, a member of the panel, noted that “Ketamine is a nasty drug.” But he recognizes the critical difference it can make in the lives of the right patients, namely, those suffering from severe depression and suicidal ideation. “We don’t take patients’ voices into account as often as we should,” he says.
Why This Matters
Because so little is known about how Esketamine actually helps the depressed brain, it’s impossible to say if and when it will ever become a first-choice therapy. As Garard Sanacora, a Yale psychiatrist, said, “This isn’t the next Prozac.” But he still noted how impactful this new drug could be. “These people don’t have hope—and now that you offer them hope, that alone is a very powerful tool.”
The approval of a ketamine-derived drug may also inspire more widespread interest in psychedelic research, which remains tabooin the U.S.