The US Food and Drug Administration (FDA) has approved a nasal spray for treatment-resistant major depressive disorder in adults. Esketamine is a chemical mirror image of ketamine. It must be taken with an oral antidepressant.
Approval was based, in part, on findings from three 4-week randomised trials. In one of the trials, a statistically significant effect on depression severity was seen in patients treated with esketamine, compared with placebo recipients. In an additional, longer study, patients who continued esketamine had a significantly longer time to relapse.
Because of the possibility for misuse, the drug was approved with a risk evaluation and mitigation strategy. Additionally, the label contains a boxed warning about risks for dissociation, sedation, and suicidal thoughts.
Patients self-administer the spray, but they must do so in a clinician's office so they can be monitored. The recommended dosing schedule is twice weekly for weeks 1–4, once weekly for weeks 5–8, and once every 1 or 2 weeks thereafter.
Esketamine will cost $590 for a 56-mg dose and $885 for an 84-mg dose. The month-long induction phase will have a list price between $4700 and $6800.