FDA Approves Johnson & Johnson's Nasal Spray for Adults with Treatment-Resistant Depression

Published: 1/21/2025, 11:42:43 PM EST

FDA Approves Johnson & Johnson's Nasal Spray for Adults with Treatment-Resistant Depression — The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. (Madalina Vasiliu/The Epoch Times)

The U.S. Food and Drug Administration (FDA) has approved a nasal spray to be used alone in adults with depression that is difficult to treat.

On Tuesday, the FDA cleared the way for Johnson & Johnson's Spravato (esketamine) nasal spray to be used without daily oral antidepressants.

This marks the first-ever standalone therapy for "treatment-resistant depression," which refers to those patients who have had an inadequate response to at least two oral antidepressants.

“Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them. For too long, healthcare providers have had few options to offer patients much-needed symptom improvement,” Dr. Bill Martin of Johnson & Johnson Innovative Medicine said in a statement.

Major Depressive Disorder (MDD) affects an estimated 21 million American adults who experience a range of symptoms such as loss of interest in daily activities, depressed mood, and changes in sleep or weight.

Previously, the FDA approved the spray to be used together with an oral antidepressant. But only about one-third of adults with MDD will not respond to oral antidepressants alone, Johnson & Johnson said. Patients often cycle through multiple oral medications and wait four to six weeks for potential relief. About 86 percent do not achieve remission after trying their third oral antidepressant.

"Now that it is also available as a monotherapy, healthcare providers have the freedom to further personalize treatment plans based on individual needs," Gregory Mattingly, founding partner of St. Charles Psychiatric Associates, said in a statement.

The nasal spray, which first entered the U.S. market in 2019, can only be administered by a health care provider due to its side effects. This includes fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time dissociation, and breathing problems.

Spravato works by targeting glutamate, which is the most abundant excitatory neurotransmitter in the brain, according to Johnson & Johnson. Esketamine is a more potent version of ketamine, an anesthetic that has also been used to treat depression.

The only other approved drug therapy for treatment-resistant depression is a combination of the antipsychotic drug olanzapine and the antidepressant fluoxetine. The treatment, however, has major long-term effects that include substantial weight gain, metabolic changes, diabetes, and high blood pressure.

Dr. Adam Kaplin, a psychiatrist with Johns Hopkins Medicine, said that the potency of esketamine can provide relief from major depression within hours, without those major side effects.

“Because it’s more potent, you can use it at a lower dose and theoretically have fewer side effects," Kaplan said in a statement. "Now that it’s available in an intranasal version and approved by the FDA, it’s more likely that insurance companies will cover the treatment."

It is not yet known if Spravato is safe and effective in children.