Johnson & Johnson's nasal spray for depression is authorized by the FDA as a sole therapy.

• The Food and Drug Administration approved Johnson & Johnson's nasal spray for use in adults with major depressive disorder that is difficult to treat, as sales of the drug continue to grow.
• Spravato, a new therapy for treatment-resistant depression, is the first standalone treatment option.
• In 2024, Spravato generated $780 million in sales during the first nine months, as doctors became more comfortable prescribing it.

On Tuesday, the Food and Drug Administration approved the use of 's nasal spray in adults with major depressive disorder that is difficult to treat, as sales of the drug continue to grow.

Spravato, a new therapy for treatment-resistant depression, is the first standalone treatment option.

In the U.S., Spravato was approved for use alongside an oral antidepressant to treat both treatment-resistant depression and major depressive disorder with suicidal thoughts or self-harm. The drug was introduced to the market in 2019.

Bill Martin, J&J's global therapeutic area head of neuroscience, stated in an interview that this medicine treats a disease that, if left untreated, depression can be potentially fatal.

Some estimates suggest that approximately one-third of the estimated 21 million U.S. adults with major depression experience symptoms such as persistent sadness, sleep disturbances, low energy, and thoughts of death or suicide, despite receiving treatment.

Dr. Gregory Mattingly, a physician and president of the Midwest Research Group, stated that for the first time ever, patients have an option that provides them with freedom. This statement was made in reference to Spravato, which was involved in the original clinical trials.

In St. Louis, Missouri, his center has treated over 6,000 patients with the drug and currently has over 100 people taking it. This center is one of the 3,000 outpatient treatment centers in the U.S. that are certified to administer Spravato, as per J&J's count.

Mattingly stated that patients have the option to take Spravato with or without an oral antidepressant, particularly if the pills are not alleviating their symptoms and are causing adverse side effects, such as weight gain and sexual problems.

Martin from J&J stated that the approval offers an opportunity for caregivers and patients to tailor treatment plans for each individual and determine the most effective way to manage the disease.

According to Martin, potentially "more patients could benefit" from Spravato.

J&J's third-quarter earnings reveal that Spravato has generated $780 million in sales during the first nine months of 2024, and the company anticipates even higher growth, with sales projected to increase between $1 billion and $5 billion annually.

J&J benefits from the upcoming patent expiration and new Medicare negotiations for its top-selling inflammatory treatment, Stelara, as it pressures sales.

The approval of Spravato for depression treatment was based on a phase four trial that demonstrated its effectiveness in reducing depressive symptoms within 24 hours of treatment and lasting for at least a month. The company has stated that the safety profile of Spravato when used alone was consistent with previous clinical data on its combination with oral antidepressants.

Martin stated that Spravato provides not only quick symptom relief but also long-lasting symptom relief when taken alone by patients.

Spravato's long road to rapid growth

In 2019, Spravato marked a new path as the first major depression treatment to receive FDA approval in over three decades. The drug is related to ketamine, a common anesthetic with hallucinogenic effects that can be misused recreationally. J&J developed it into a nasal spray to quickly reach the brain.

Mattingly stated that Spravato activates neural networks in a unique manner.

"Spravato can provide quick relief, with people starting to feel better within a day or two," he said.

Due to the potential side effects such as sedation, dissociation, respiratory depression, and suicidal thoughts, as well as the risk of abuse or misuse, Spravato is only available through a restricted program. This means that it cannot be purchased at a pharmacy and can only be administered in certified healthcare settings under strict supervision.

Patients must be monitored by a healthcare professional for two hours after taking the medication.

Despite initial difficulties due to pandemic-related complications, J&J increased marketing efforts for Spravato after in-person doctor visits became more common, resulting in increased awareness among physicians of its benefits.

"At that point, the mental health community wasn't accustomed to performing procedures, having a designated space, or considering how to administer Spravato. However, after witnessing the positive effects on patients, many of us have become strong advocates for it," Mattingly stated.

According to J&J's Martin, a five-year study of the drug's effectiveness and a head-to-head comparison with an oral antidepressant boosted doctors' confidence in Spravato's superior efficacy.