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Novel Molecular Targets for Mood Disorders and Psychosis Proceedings of a Workshop (2021) / Chapter Skim
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6 Regulatory Considerations for the Next Generation of Psychiatric Drugs
Pages 41-46

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From page 41...
... . • Both esketamine and brexanolone received breakthrough therapy designation, were granted priority reviews, convened public advisory committee meetings, and used risk evaluation and mitigation strategies included as part of their approvals (Farchione)
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From page 42...
... Farchione noted that for traditional antidepressants, FDA has allowed maintenance studies to be conducted after market approval through randomized withdrawal studies because experience has demonstrated that these treatments continue to work. However, for novel antidepressants, data are needed to demonstrate appropriate dosing regimens over the long term for this chronic cyclical illness.
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From page 43...
... Because prior experience with traditional antidepressants is not applicable to drugs approved under a novel paradigm, Farchione said, FDA informed the submitting drug development company that it would not be sufficient to demonstrate an acute treatment effect to gain approval, but that they would also need to provide long-term data. In this case, the drug development company opted to conduct a trial supporting its unique dosing approach in which dosing changes over the course of treatment, starting with twice per week in the induction phase followed by once weekly or once every 2 weeks in the maintenance phase, she added.
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From page 44...
... Interestingly and unexpectedly, participants who received the intranasal placebo also improved when they switched their oral antidepressants; however, those in the esketamine group improved more, which led to the product approval, she said. THE APPROVAL OF BREXANOLONE Prior to the introduction of brexanolone, PPD was treated similarly to an episode of major depressive disorder, said Farchione.
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From page 45...
... , which was used in the esketamine trials, nor the HDRS are particularly good for detecting early signals of efficacy because many of the items rated by these measures would not be expected to change quickly. She said FDA accepted letters of intent for two patient-reported clinical outcome measures in development that focus on recall of depression symptoms over hours rather than days.
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From page 46...
... SOURCES: Presented by Tiffany Farchione, March 9, 2021; brexanolone full prescribing information, initial approval, March 19, 2019.
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Key Terms

  • drug development
  • oral antidepressant
  • regulatory considerations
  • novel antidepressants
  • dosing regimens

  • treatment effect
  • development company
  • rapidly acting
  • tiffany farchione
  • public advisory

  • initial approval
  • committee meetings
  • submitting drug
  • alternative dosing
  • therapy designation

  • depressive disorder
  • trial participants
  • scribing information
  • priority reviews
  • major depressive

  • brexanolone received
  • intranasal esketamine
  • eligible trial
  • treatment curves
  • granted priority

  • clinical trials
  • fda informed
  • cyclical illness
  • phase followed
  • rating scale


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