Johnson & Johnson is seeking an expanded approval from the Food and Drug Administration for its ketamine-related antidepressant Spravato.
J&J on Monday said it has filed an application with the agency for Spravato, a nasal spray, to be used as a monotherapy for adults with treatment-resistant depression. Currently, it’s cleared for use together with an oral antidepressant.
Backing the company’s submission is data from a Phase 4 trial showing monotherapy Spravato eased depressive symptoms beginning about 24 hours after treatment and lasting through at least one month.
The drug was first approved in 2019 for adults with depression who had not improved on other antidepressants. Clinical results presented at the time were mixed and the drug was given a black box warning due to its risks, however. The therapy has since been used by over 100,000 people across the 77 countries in which it is approved, according to J&J.
Spravato is closely related to ketamine, a dissociative anesthetic that can have hallucinogenic effects. The drug’s label warns of the risk of sedation and dissociation, respiratory depression, as well as suicidal thoughts and behaviors and abuse or misuse of the drug. Because of possible side effects, Spravato is only available through a restricted program, and users of the medication must be monitored by a healthcare professional for two hours following administration.
According to J&J, roughly 30% of the estimated 280 million people with major depressive disorder have treatment-resistant depression. Management can be difficult, as it involves trying different medication combinations, increasing dosing or giving treatments more time to show a benefit.
"Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don't effectively resolve their symptoms," said Bill Martin, J&J’s neuroscience head, in the company’s statement
Sales of Spravato have steadily increased in recent quarters as doctors grow more comfortable with using the drug, J&J executives said on a recent earnings call. If current trends hold, sales could surpass $1 billion this year.
The Phase 4 study of Spravato was a randomized, double-blind placebo controlled trial evaluating the drug’s benefit on a depression rating scale known as MADRS. The company said the safety profile was consistent with previous clinical data on Spravato’s use in combination with oral antidepressants.
