In one of the most significant milestones for depression treatment in decades, the U.S. Food and Drug Administration announced today that it has approved a new drug with esketamine, a derivative of ketamine.
Made by Johnson & Johnson under the brand name Spravato, the drug is meant to be taken as a nasal spray in conjunction with an oral antidepressant and targets patients who have not responded to other treatments. Spravato is the first major new depression treatment to be approved by the FDA since Prozac, which had less side effects than older antidepressants, hit the market more than 30 years ago, and is especially notable because it is supposed to work much more quickly than other drugs.
This is the first time the FDA has approved esketamine for any use (it approved ketamine as an anesthetic in 1970). Despite ketamine’s reputation as a recreational drug, doctors have been prescribing it off-label for years to patients who have not responded to antidepressants and other treatments. The FDA’s advisory committee voted 14-2 (with one abstention) for its approval last month.
The FDA approved esketamine with the caveat that Spravato will only be available through REMS (Risk Evaluation and Mitigation Strategies), its restricted distribution system for drugs with major safety concerns, citing the risk of sedation and dissociation, as well as the potential for abuse and misuse. Patients administer the nasal spray themselves, but they only will be allowed to do so in a doctor’s office or clinic, and cannot take Spravato home with them.
Spravato’s effectiveness was evaluated in three short-term clinical trials, as well as one longer trial. One of the short-term studies, each four weeks long, found that the combination of Spravato and an oral antidepressant demonstrated a “statistically significant effect” compared to a placebo, sometimes within two days (the other two short-term trials did not meet pre-determined statistical tests for effectiveness).
In the longer trial, patients who had stabilized and continued with the medication combo took a “statistically significant longer time” to relapse than patients who received a placebo nasal spray with their oral antidepressant.