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Nasal Spray Treating Major Depression Receives FDA Approval For Standalone Use

The Food and Drug Administration has approved Johnson & Johnson's nasal spray as a standalone treatment for severe forms of depression, officials said.

The FDA approved the nasal spray drug Spravato for use as a monotherapy for adults with depression.

The FDA approved the nasal spray drug Spravato for use as a monotherapy for adults with depression.

Photo Credit: Johnson & Johnson (left) and FDA (right)

The FDA granted approval to Spravato (esketamine) as the first monotherapy for adults with treatment-resistant depression, J&J said in a news release on Tuesday, Jan. 21. The decision came after a priority review of clinical data showing significant improvements in depression symptoms as early as 24 hours and sustained progress through four weeks.

According to J&J, treatment-resistant depression affects about one-third of the estimated 21 million U.S. adults living with major depressive disorder.

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

Spravato was previously used in combination with oral antidepressants but can now be prescribed on its own. The FDA first approved the spray drug back in 2019.

Healthcare providers prescribing Spravato must follow a restricted program under a Risk Evaluation and Mitigation Strategy program. The strategy is put in place due to risks of sedation, dissociation, slowed breathing, and potential abuse.

Dr. Gregory Mattingly, president of Midwest Research Group, studied Spravato during early clinical trials.

"For more than six years, I've seen firsthand the real-world impact Spravato can have on patients' lives," Dr. Mattingly said. "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."

J&J said Spravato works by targeting glutamate, the brain's most abundant chemical that sends messages from the brain to the body by stimulating nerve cells. While its exact mechanism remains unknown, its fast-acting nature has transformed the outlook for patients.

Spravato has been given to more than 140,000 patients globally, with approvals in 77 countries.

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