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Johnson & Johnson's Spravato nasal spray okayed as stand-alone treatment for depression
Spravato, okayed for stand-alone use among adults, is the first such therapy for major depressive disorder (MDD) that is difficult to treat.
The United States Food and Drug Administration (FDA) has approved Spravato (esketamine), a nasal spray from Johnson & Johnson, as a stand-alone therapy for adults with major depressive disorder (MDD) that is difficult to treat, according to a statement by the company.
Spravato is, therefore, the first-ever stand-alone therapy for MDD, a condition in which the depression symptoms of a patient show inadequate response to at least two oral antidepressants.
The drug, which first entered the market in 2019, was previously cleared to be used together with an oral antidepressant for both treatment-resistant depression and MDD patients experiencing thoughts of suicide or harm.
“Treatment-resistant depression can be very complicated. For too long, healthcare providers have had few options to offer patients much-needed symptom improvement,” the statement quoted Bill Martin of Johnson & Johnson and saying.
“With Spravato now approved as a stand-alone, patients may experience improvement in depressive symptoms as early as 24 hours and at 28 days, without the need for daily antidepressants,” Martin added.
An estimated 21 million (2.10 crore) adults in the US have MDD, making it one of the most common psychiatric disorders, the US pharmaceutical giant noted.
Approval based on phase 4 trial
The approval for Spravato is based on a phase four trial, which showed that the Johnson & Johnson nasal spray on its own led to a ‘rapid improvement’ in depressive systems beginning about 24 hours after treatment and lasting through at least four weeks or 28 days.
Spravato becoming a ‘blockbuster product’
As per the third quarter earnings of Johnson & Johnson, Spravato brought in sales worth $780 million (roughly Rs. 6,747 crore) during the first nine months of 2024.
In December, the company told investors that its expectations for Spravato are that will generated sales between $1 billion and $5 billion annually.
