Major depressive disorder (MDD) is characterised by characterised by depression and inability to feel pleasure. Credit: Justin Paget via Getty Images.

Johnson & Johnson’s (J&J) nasal spray Spravato (esketamine) has received a label expansion, now approved as a monotherapy treatment for major depressive disorder (MDD) in adults who do not respond to two oral antidepressants.

The US Food and Drug Administration’s (FDA’s) decision makes Spravato the first-ever standalone treatment for adults with treatment-resistant depression. Initially approved in 2019 for use alongside oral antidepressants, this label expansion follows a priority review from the FDA.

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The approval was based on data from the Phase IV TRD4005 study (NCT04599855), which demonstrated a significant reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) total score within 24 hours after the initial dose, with effects sustained for at least four weeks. Spravato’s safety profile aligns with existing data for oral antidepressants, with no new safety concerns detected.

The standard-of-care for MDD typically involves selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) as first-line treatments, often in combination with psychotherapy. However, these therapies can take weeks to exert an effect, and many patients do not respond adequately, leading to a need for innovative alternatives.

Spravato targets the brain’s N-methyl-D-aspartate (NMDA) receptor. Unlike traditional MDD therapies that usually take weeks to work, J&J says this drug delivers rapid action.

MDD is a severe, chronic mood disorder characterised by depression, inability to feel pleasure, guilt, low energy, and impairments in essential functioning. The global MDD market, valued at $8.8bn in 2019, is expected to grow to $16.2bn in 2029, according to a GlobalData report.

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GlobalData notes that growth will be driven by the rising patient share of newly approved drugs, including J&J’s Spravato. Generating $689m in 2023 – nearly double its 2022 revenue of $374m – the drug’s sales are projected to reach $2.6bn by 2030. 

Another key contributor to this growth is Axsome Therapeutics’ Auvelity (dextromethorphan and bupropion). The company submitted a new drug application for Auvelity to the FDA for the treatment of MDD, which was accepted under priority review in April 2021. The FDA then approved Auvelity extended-release tablets in August 2022. Axsome’s drug is forecast to generate $1.9bn by 2030.

With researchers looking for alternative treatments for mental health conditions, psychedelics have gained investor attention in recent years after demonstrating success in clinical trials. Psilocybin, a psychedelic prodrug compound found in more than 200 species of fungi, is currently in a Phase III programme for treatment-resistant depression with Compass Pathways.