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US FDA Opens Door For J&J's Spravato To Another MDD Population

Executive Summary

The US FDA approved the esketamine nasal spray for adults with major depressive disorder with suicidal ideation or behavior, following its initial approval in 2019 for treatment-resistant depression. 

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Psychedelics For CNS Disorders: Understanding The Opportunity

Investigational uses of psilocybin and MDMA – two illicit drugs associated with recreational use and abuse in the US – will soon enter the later stages of clinical development for the treatment of CNS disorders including depression, addiction and post-traumatic stress disorder. Janssen’s experiences marketing Spravato, an inhaled form of ketamine indicated for severe forms of depression, may be instructive for companies working to bring other psychoactive compounds into mainstream use as therapeutics.         

Janssen to Address NICE's Concerns Following Another English Funding No For Spravato

UK health technology assessment body NICE says the cost-effectiveness estimates for the nasal spray for treating hard-to-treat depression are much higher than what it considers to be cost-effective.

After Another NICE No, Will It Be Third Time Lucky For J&J's Spravato?

The healthcare giant's nasal spray for hard-to-treat depression has been rejected for use on the UK's NHS for a second time because of uncertainty over cost, but comments on this consultation could result in a change of fortunes for the potential blockbuster.

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