US FDA Opens Door For J&J's Spravato To Another MDD Population
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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The speed and efficacy of psilocybin candidate COMP360 in treatment-resistant depression in a Phase II study could outweigh the major safety events also seen.
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.
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.