Approved for treatment-resistant depression (TRD) in March of 2019, esketamine is now approved to treat depressive symptoms in adults with major depressive disorder (MDD) and acute suicidal ideation or behavior.
Dozens of antidepressants have been approved over the years. These include Eli Lilly’s “blockbuster” drug Prozac, which was approved in 1987. But there haven't been any new advancements in other types of antidepressants that work in different ways.
Esketamine offers the first new mechanism of action in 30 years to treat MDD.
Since its initial approval, esketamine has been prescribed to about 6,000 patients.
This medication is available as a nasal spray and is to be given with an oral antidepressant (taken by mouth). The recommended dose is 84 mg twice per week for four weeks. After four weeks, your health care provider will evaluate the benefit and decide whether you will need to continue treatment.
The FDA approved the new use for this drug based on data from two phase 3 trials. The trials found that people who were given esketamine plus standard care had reduced depressive symptoms within 24 hours.
"Traditional oral antidepressants need weeks or more to take effect, so the availability of a medicine that can begin providing relief within a day is potentially life changing," said Theresa Nguyen, chief program officer for Mental Health America, in a press release from Janssen, a pharmaceutical company.
The effectiveness of esketamine in preventing suicide or reducing suicidal ideation or behavior has not been demonstrated, according to Janssen.
Johnson & Johnson’s esketamine is very close in structure to ketamine, which is known as a psychedelic club drug. This medication is only available through a restricted distribution system under a Risk Evaluation and Mitigation Strategy (REMS). That's because this medication may cause serious side effects, such as drowsiness and disassociation (a sense of being detached from yourself and your emotions). There is also a potential for abuse and misuse of this medication.
This medication is to be self-administered in a certified treatment center under the supervision of a health care professional. In addition, those who receive this medication are to be monitored for two hours after the dose is given.
Patients will need to make arrangements to safely leave the medical office to get home and are instructed not to drive or use heavy machinery for the rest of the day.
Common side effects of esketamine include dizziness, sleepiness, increased blood pressure, vomiting, vertigo and elevated mood. Potentially serious side effects tied to esketamine include suicidal thoughts and behaviors. These potential effects are noted in esketamine's boxed warning (the strongest type of medication warning).
Esketamine's new indication approval was granted to Janssen Pharmaceuticals, Inc.