FDA Approves Medication for Treatment-Resistant Depression
Spravato™ nasal spray (esketamine) was recently approved by the U.S. Food and Drug Administration in early March of 2019 for the treatment of depression in adults in conjunction with an oral antidepressant. Specifically, it is to be used by depressed adults who have not benefited from other antidepressant medications (these adults would be diagnosed with treatment-resistant depression). This nasal spray is a chemical variant of ketamine nasal spray, a party drug known as “Special K.”
With this newly approved nasal spray, there is a risk of adverse reactions from use; in addition, there is a potential for misuse and abuse of the drug. Therefore, it is currently available only through a tightly controlled distribution system from pre-approved prescribers. It must also be given in certified locations with patients closely monitored.
FDA-Approved, but Still Heavily Restricted
The need for additional treatments that are effective in combating treatment-resistant depression has been a long-standing one. Tiffany Farchione, M.D., acting Director of the Division of Psychiatry Products in the Center for Drug Evaluation and Research for the FDA explains, “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. Because of safety concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient.”
Could the New Ketamine Nasal Spray Help You or Someone You Know?
This new FDA-approved medication is for patients with drug-resistant major depressive disorder; patients must have tried at least two different antidepressant treatments for an adequate trial of time without responding satisfactorily to the treatments in order to be considered for Spravato™ nasal spray.
Cautions Regarding Spravato™ (Esketamine) Nasal Spray
Patients who use Spravato™ are at risk for difficulty with judgment, thinking, and attention; the risk for sedation and misuse exists, in addition to suicidal thoughts and behaviors after taking the drug. It is for these reasons that patients must remain at a certified administration office for at least two hours after receiving each dose. Patients and prescribers must sign forms that clearly state that the patient must not drive or operate heavy machinery for the rest of the day, and he or she must make arrangements to safely leave the office to arrive at home.
The nasal spray for depression cannot leave the premises; the patient does administer it to himself or herself under the provider’s supervision. It falls upon the provider’s discretion to determine when the patient is satisfactory to leave.
Effects of Esketamine Spray: How It Works
This approved variant of ketamine nasal spray binds to NMSA-receptors when administered in low doses and blocks the re-uptake of glutamate. This activates AMPA receptors, which are areas of the brain responsible for regulating mood, motivation, and memory. Prior to FDA approval, some practitioners had been giving ketamine doses to patients intravenously and saw immediate results that were long-lasting. Unlike treatment with traditional antidepressants, patients only need nasal treatments once a week or once every two weeks.
Effects of ketamine nasal spray are similar to those of the intravenous version; side effects are temporary and usually are few. These can include dizziness, vertigo, anxiety, nausea, an increase in blood pressure, sedation, dissociation, and decreased sensitivity.
An Effective, Quick Treatment Option
Ketamine nasal spray can provide fast results with few short-term side effects; unlike traditional antidepressant medications, with which patients wait weeks to start to see results, the nasal spray produces almost immediate, noticeable changes. Patients will be able to see quickly whether there will be a continued benefit for a prolonged time.
The FDA approval of the esketamine nasal spray for drug-resistant depression is a major step in the right direction for the treatment of mental illness. As a qualitatively different alternative to mainstream antidepressants, it can help millions of adults with drug-resistant depression who, until now, have found no help for their suffering.
