Johnson & Johnson, FDA

Photo Courtesy of Johnson & Johnson

FDA Approves Johnson & Johnson Nasal Spray for Depression

January 21, 2025

Lucille Barilla

The Food and Drug Administration (FDA) has approved a nasal spray developed by Johnson & Johnson for depression.

A Johnson & Johnson press release shared that SPRAVATO is now the first and only monotherapy for adults with treatment-resistant depression. Patients who live with major depressive disorder or MDD and who previously tried at least two oral antidepressants without success would most benefit from this new depression drug.

“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,” said Bill Martin, Ph.D., global therapeutic area head of neuroscience at Johnson & Johnson Innovative Medicine. “SPRAVATO is now available as a standalone treatment, meaning patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days — without the need for daily oral antidepressants.”

“For more than six years, I’ve seen firsthand the real-world impact SPRAVATO can have on patients’ lives,” said Gregory Mattingly, M.D., president of Midwest Research Group and founding partner of St. Charles Psychiatric Associates. “Now that it is also available as a monotherapy, healthcare providers have the freedom to further personalize treatment plans based on individual needs, so patients can experience the efficacy of SPRAVATO in as little as 24 hours, through day 28, without the need for a daily oral antidepressant.”

The approval for this depression drug was given to Johnson & Johnson following an FDA Priority Review. During a testing period, patients who took SPRAVATO showed improvement in their symptoms. Results showed that by day 28 of taking this depression medication, 22.5% of patients achieved remission compared to 7.6% who took a placebo.

Although FDA-Approved, SPRAVATO Is Only Available Via a Doctor-Restricted Program

Even though SPRAVATO is FDA-approved, that doesn’t mean it can be dispensed by or to just anyone. This drug is only available via the SPRAVATO Risk Evaluation and Mitigation Strategy (REMS) Program.

The Associated Press reported that SPRAVATO’s active ingredient, Esketamine, is a chemical cousin of ketamine. The medication targets a chemical called glutamate that is believed to restore brain connections to help alleviate depression symptoms.

According to the DEA, “Ketamine can induce a state of sedation (feeling calm and relaxed), immobility, relief from pain, and amnesia (no memory of events while under the influence of the drug) and is abused for the dissociative sensations and hallucinogenic effects.” Thus, patients taking this drug will be closely monitored by their doctors and given the proper amount of FDA-approved SPRAVATO to alleviate their symptoms.

“This is going to bring in some standards, regulation and it’s going to make it safer and more accessible to patients,” said Dr. Steve Levine, the vice president of the American Society of Ketamine Physicians, of the medication’s proper use.

According to the Johnson & Johnson, patients should not take SPRAVATO if they have the following conditions:

  • A blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms, and legs).
  • An abnormal connection between the veins and arteries (arteriovenous malformation).
  • A history of bleeding in the brain.
  • An allergy to esketamine, ketamine, or any other ingredients in SPRAVATO.

In 2019, the FDA noted that some of the most common side effects experienced by patients who took the drug in clinical trials include “disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk.”

Depending on the dosage and various insurance discounts and rebates, the drug will cost between $590 and $885. It can only be dispensed by specialists who will monitor patients after dosing for at least two hours after administration. These patients will also continue to be monitored for the drug’s long-term safety and effectiveness.

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