Federal regulators approved Johnson & Johnson’s (NYSE: JNJ) nasal spray Spravato as the first stand-alone therapy for adults with treatment-resistant depression.
The Food and Drug Administration announced its decision last week that allows Spravato use without requiring oral antidepressants. The FDA had previously mandated that Spravato be used in combination with antidepressants.
According to J&J, the treatment demonstrated superior improvement in depressive symptoms compared to placebo as quickly as 24 hours after administration, with benefits sustained through 28 days.
“Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them,” Bill Martin, global therapeutic area head of neuroscience at J&J’s Innovative Medicine unit, said in a statement.
According to the data of the company, in clinical trials, 22,5% of patients treated with Spravato experienced remission within four weeks compared to only 7.6% who were on placebo.
The treatment targets glutamate, the brain’s most prevalent excitatory neurotransmitter – which prompts sharing rather than inhibiting information between neurons – representing a different mechanism than traditional antidepressants. But the exact mechanism of how the treatment works is still unknown, according to the company.
Major depressive disorder affects approximately 21 million adults in the U.S., with roughly one-third not responding adequately to conventional antidepressants, J&J reported. This condition is a significant financial burden, especially for treatment-resistant patients.
A restricted program will be implemented to continue the availability of this medication due to its risks. These include sedation as well as potential for misuse. The drug must be administered in a certified facility where the patient can be closely monitored for two hours following administration.
Spravato, a treatment approved in 2006, has now been used by more than 140.000 patients worldwide, says the company. It is approved now in 77 different countries.
The treatment has gained significant commercial traction, becoming Johnson & Johnson’s newest “billion-dollar brand” after surpassing $1 billion in annual sales for 2024, according to company executives. In an earnings call last Tuesday, Jennifer Taubert, J&J’s executive vice president, noted the drug’s growth of 45.3% was driven by “increased physician and patient confidence” in the treatment.
Other companies are racing to create novel depression treatments. Some have faced setbacks. Compass Pathways is currently testing a treatment for depression resistant to conventional treatments based on psilocybin. The company recently announced that it will cut 30% of their workforce, and postpone key results until mid-2025. RBC Capital Markets estimated that the drug would generate a peak sale of $2.3 billion, if it were approved. However, the company faced challenges in maintaining blindness in the psychedelic trials.