J&J's Spravato gets another lift with new FDA approval

The accelerating sales growth of Johnson & Johnson's Spravato could go up yet another gear after the FDA approved a third indication for the novel antidepressant.
Spravato (esketamine) has become the first standalone therapy to be cleared by the US regulator for adult patients with treatment-resistant depression (TRD), extending its 2019 approval for use in combination with other antidepressant drugs. Since then, Spravato has also been given the go-ahead for use in people with major depressive disorder (MDD) who have suicidal thoughts or behaviours.
The new labelling gives a new option to patients who are failing to get relief from depression despite trying multiple treatment regimens, or who are struggling to tolerate them, and could allow Spravato to be used earlier in the treatment pathway.
After a slow start in the market – perhaps reflecting hesitancy on the part of doctors in prescribing a medicine derived from a scheduled compound (ketamine) that is misused as a recreational drug – Spravato's efficacy in hard-to-treat depression has driven a rapid increase in prescribing.
Sales rose almost two-thirds in the first nine months of 2024 to $780 million, setting the drug on course to cross the $1 billion threshold for the full year.
The FDA approval comes after a priority review and is based on the results of the TRD4005 study reported at the American Society of Clinical Psychopharmacology (ASCP) annual meeting last year, which showed that Spravato administered as a nasal spray achieved a rapid and statistically significant improvement in depressive symptoms over placebo when used as a monotherapy in TRD.
After four weeks, 22.5% of patients taking J&J's drug were in remission – defined as a score of 12 or below on the Montgomery-Åsberg Depression Rating Scale (MADRS) – compared to 7.6% of the placebo group. In some patients, there was a measurable shift on the MADRS scale within around 24 hours of the first dose, according to J&J.
That speed of onset has been held up as the main benefit for Spravato compared to other approaches to treatment-resistant depression, which often rely on sequentially trying different oral therapies that can take weeks to confer a benefit – if they are effective at all.
"Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them," said J&J's head of neuroscience, Bill Martin.
"For too long, healthcare providers have had few options to offer patients much-needed symptom improvement," he added.
Around 21 million adults in the US live with MDD, and around a third of them do not respond to standard, oral antidepressant therapies. So far, Spravato has been used to treat around 140,000 people worldwide, according to J&J.