Johnson & Johnson’s standalone nasal spray for depression gets FDA nod

The spray is a first of its kind, as it provides a stand-alone solution for treatment-resistant depression which is when at least two standard treatments fail to ease depression symptoms. 

The United States Food and Drug Administration (FDA) has approved Spravato, a nasal spray by Johnson & Johnson as a stand-alone treatment for adults with Major Depressive Disorder (MDD). 

The spray is a first of its kind, as it provides a stand-alone solution for treatment-resistant depression which is when at least two standard treatments fail to ease depression symptoms. 

The spray first entered the US market in 2019 and was previously cleared to be used together with an oral antidepressant for treatment-resistant depression as well as for treating patients with MDD experiencing thoughts of suicide and harm. 

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Usage and more

Spravato can be used with or without an oral antidepressant especially if pills cause unwanted symptoms like weight gain or sexual issues. The spray in its phase 4 trial showed a ‘rapid improvement’ of depressive symptoms with effects starting within 24 hours of treatment and lasting through 28 days.  

In 2019, Spravato became the first new major depression treatment to win FDA approval in more than three decades. The drug, Esketamine, is related to ketamine, which is a common anesthetic and is also sometimes misused recreationally due to its hallucinogenic effects. Making it a nasal spray makes it so that the drug reaches the brain more quickly.  

Potential side effects of the spray include risk of sedation and dissociation, respiratory depression, suicidal thoughts, and abuse or misuse of the drug. Therefore the drug cannot be purchased at pharmacies but can only be availed through a restricted program. It is only administered in certified health-care settings under strict supervision and users must be monitored by healthcare professionals for at least two hours after administration. 

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Johnson & Johnson’s drug expected to hit USD 1-5 billion in annual sales

21 million adults in the US are estimated to have MDD, making it one of the most common psychiatric disorders. Spravato brought in sales worth 780 million USD during the first nine months of 2024 and is expected to increase its sales between 1 billion USD and 5 billion USD annually.

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