After years of clinical trials, including those at Sharp Mesa Vista Hospital, the federal Food & Drug Administration (FDA) recently approved a new treatment for major depression. The intranasal spray, known as esketamine, is a safe, very low dose of ketamine — a powerful anesthetic — proven to reduce symptoms of severe depression.
"Not all patients respond positively to traditional treatments," he says. Traditional treatments include talk therapy and oral antidepressants. "Now we will have another option to help these patients. I'm proud of the work Sharp has done to help understand the role esketamine can play in treating depression."
Here's what you need to know about the new FDA-approved intranasal spray treatment, esketamine.
What did the FDA approve?
The FDA approved the use of safe, low doses of esketamine, administered as a nasal spray, under the brand name Spravato™. The approval was the result of years of rigorous clinical trials, monitoring and FDA review.
How does it work?
The fast-acting drug is thought to affect neurotransmitters in the brain, restoring synapse connections in the brain that are disrupted during major depressive disorder. Research has shown that supervised use of esketamine may also help reduce suicidal thoughts. The effects are felt almost immediately, as opposed to the several weeks it may take to feel significant relief from antidepressant medications.
Who is eligible for the new treatment?
The drug will be prescribed to patients with major depressive disorder who have not responded positively to at least two other antidepressant treatments.
How will it be administered?
Esketamine will not be administered by patients; it will be available at approved and certified treatment centers, under the supervision of a clinician.
Why is it controversial?
Esketamine in higher doses can be used as a recreational drug, and can produce hallucinations and other potentially harmful side effects. The approved therapeutic dose is much smaller, although not without side effects, which can include dizziness, drowsiness and elevated blood pressure. The most serious side effects include dissociative or "out-of-body" episodes very shortly after taking the drug, which is why it will be administered under supervision in a licensed facility.
Is esketamine addictive?
While clinical trials tested the safe use of esketamine for depression for up to one year, its effect over a longer period was not tested.
Will insurance pay for this new treatment?
Although FDA approval of a new drug often results in coverage by insurance companies, each provider has its own process. Patients who are interested in this treatment option should talk with their doctor and insurance provider.
The Clinical Research Center at Sharp Mesa Vista Hospital has conducted more than 300 clinical trials dedicated to developing new and more effective mental health treatments. Learn more about the Alzheimer's disease and schizophrenia trials currently enrolling at Sharp Mesa Vista.