The Food and Drug Administration has approved Johnson & Johnson's nasal spray Spravato (esketamine) as a standalone treatment for adults with treatment-resistant depression. This landmark decision makes Spravato the first-ever monotherapy of its kind, offering hope for individuals who have not responded to at least two standard antidepressant therapies.
"This is a medicine that treats a disease that, when left untreated, is potentially fatal," said Bill Martin, J&J's global head of neuroscience, in an interview. The approval comes as depression rates continue to rise, with an estimated 21 million adults in the U.S. experiencing major depressive disorders, according to federal data. Of these, about one-third struggle with symptoms that traditional treatments fail to address.
Spravato's new designation expands its initial FDA approval in 2019, which allowed its use only alongside oral antidepressants. Physicians and researchers are hailing the approval as a significant breakthrough in mental health treatment. "For the first time ever, we now have an option that gives patients freedom," said Dr. Gregory Mattingly, president of the Midwest Research Group and a clinical trial investigator for Spravato.
The drug, administered via nasal spray, offers rapid symptom relief, often within hours, by targeting NMDA receptors in the brain, a mechanism different from traditional antidepressants. This innovation has been credited with turning the tide for patients who have endured long waits for relief under conventional treatments. "Our standard oral antidepressants took weeks to months to see if they're going to work," Mattingly explained. "With Spravato, people can already start to feel somewhat better the very next day."
Despite its promise, Spravato comes with notable caveats. Due to its potential side effects, which include sedation, dissociation, and respiratory depression, the drug is only available through certified healthcare settings under strict supervision. Patients must remain under observation for two hours after each administration.
The FDA's decision follows a phase four clinical trial that demonstrated the drug's effectiveness as a standalone therapy, with improvements in depressive symptoms evident within 24 hours and lasting for at least a month. Johnson & Johnson highlighted that the safety profile was consistent with prior studies involving Spravato in combination with oral antidepressants.
Spravato's approval is expected to drive its growth in the mental health market. In 2024, the drug generated $780 million in revenue during the first nine months, a 60% increase from the same period in 2023. J&J has projected that Spravato could bring in annual sales ranging from $1 billion to $5 billion in the coming years.
The drug's success offers a financial buffer for Johnson & Johnson, which is facing challenges such as an upcoming patent expiration for its top-selling drug Stelara and new Medicare-negotiated pricing pressures. The company's shares rose nearly 1% following the FDA announcement.
Spravato's journey has not been without obstacles. Its initial launch was hindered by pandemic-related challenges, which complicated the administration requirements of the drug. However, with increased marketing and greater awareness among physicians, the treatment has gained traction. "The mental health community wasn't really used to doing procedures at that point," said Mattingly. "Now, we've all seen the benefits to our patients, and many of us have become strong advocates" for it.
