J&J requests broader approval for Spravato antidepressant

Johnson & Johnson is pursuing expanded approval from the Food and Drug Administration (FDA) for Spravato, a nasal spray used to treat depression. On Monday, the company announced that it has submitted an application to the FDA for Spravato to be used as a standalone treatment for adults with treatment-resistant depression. Currently, the medication is approved only for use alongside an oral antidepressant.

The company's submission is supported by data from a Phase 4 clinical trial. The trial showed that using Spravato alone alleviated depressive symptoms as early as 24 hours after administration, with effects lasting for at least one month. Spravato was initially approved in 2019 for adults whose depression had not improved with other antidepressants. At the time, clinical results were mixed, and the drug received a black box warning due to its potential risks. Despite this, more than 100,000 people across 77 countries have used Spravato since its approval, according to Johnson & Johnson.

Spravato is chemically related to ketamine, a dissociative anesthetic known to cause hallucinogenic effects. The drug's label includes warnings about sedation, dissociation, respiratory depression, suicidal thoughts and behaviors, and the potential for abuse or misuse. Due to these severe side effects, Spravato is only accessible through a restricted program, and patients must be monitored by healthcare professionals for two hours after taking the medication.

Johnson & Johnson notes that approximately 30% of the estimated 280 million people with major depressive disorder suffer from treatment-resistant depression. Managing this condition is challenging and often involves trying different combinations of medications, adjusting dosages, or allowing more time for treatments to take effect. "Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don't effectively resolve their symptoms," Bill Martin, Johnson & Johnson's neuroscience head, stated in the company's announcement.

Sales of Spravato have been steadily increasing in recent quarters, as doctors become more comfortable prescribing the drug. Johnson & Johnson executives noted in a recent earnings call that if the current trend continues, sales could surpass $1 billion this year.

The Phase 4 study of Spravato was a randomized, double-blind, placebo-controlled trial that evaluated the drug’s effect on a depression rating scale known as MADRS (Montgomery-Åsberg Depression Rating Scale). Johnson & Johnson reported that the safety profile observed in this study was consistent with previous clinical data on the use of Spravato in combination with oral antidepressants.