CNS Drug Development: Lessons from the Development of Ondansetron, Aprepitant, Ramelteon, Varenicline, Lorcaserin, and Suvorexant. Part I

@article{Preskorn2014CNSDD,
  title={CNS Drug Development: Lessons from the Development of Ondansetron, Aprepitant, Ramelteon, Varenicline, Lorcaserin, and Suvorexant. Part I},
  author={Sheldon H. Preskorn},
  journal={Journal of Psychiatric Practice},
  year={2014},
  volume={20},
  pages={460–465}
}
  • S. Preskorn
  • Published 1 November 2014
  • Psychology
  • Journal of Psychiatric Practice
This column is the first in a two-part series exploring lessons for psychiatric drug development that can be learned from the development of six central nervous system drugs with novel mechanisms of action over the past 25 years. Part 1 presents a brief overview of the neuroscience that supported the development of each drug, including the rationale for selecting a) the target, which in each case was a receptor for a specific neurotransmitter system, and b) the indication, which was based on an… 

CNS Drug Development, Lessons Learned, Part 5: How Preclinical and Human Safety Studies Inform the Approval and Subsequent Use of a New Drug—Suvorexant as an Example

  • S. Preskorn
  • Medicine, Biology
    Journal of psychiatric practice
  • 2018
TLDR
This column illustrates how targeting the drug to one mechanism out of hundreds yields increased safety and highlights the importance of the package insert which summarizes the results of all of the studies from the drug’s development program.

CNS Drug Development, Lessons Learned, Part 4: The Role of Brain Circuitry and Genes—Tasimelteon as an Example

  • S. Preskorn
  • Biology, Psychology
    Journal of psychiatric practice
  • 2017
This is the fourth in a series of columns discussing the rational and targeted development of drugs to affect specific central nervous system (CNS) circuits in specific ways based on knowledge gained

CNS Drug Development: Lessons Learned Part 3 Psychiatric and Central Nervous System Drugs Developed Over the Last Decade—Implications for the Field

  • S. Preskorn
  • Psychology, Medicine
    Journal of psychiatric practice
  • 2017
TLDR
The column discusses the reasons behind the different rates of development of psychiatric and/or central nervous system drugs compared with drugs in the areas of infectious disease, oncology, and immunology and predicts that this situation will change over the next century as the authors develop an improved understanding of the neurobiology underlying specific psychiatric illnesses.

Drug Development in Psychiatry: The Long and Winding Road from Chance Discovery to Rational Development.

  • S. Preskorn
  • Psychology, Biology
    Handbook of experimental pharmacology
  • 2019
TLDR
This chapter reviews drug development in psychiatry with an emphasis on antidepressants from 1950s to the present and then looks forward to the future including six novel mechanisms of action CNS drugs which have been successfully developed and marketed over the last 25 years.

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  • S. Preskorn
  • Psychology
    Journal of psychiatric practice
  • 2022
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  • S. Preskorn
  • Medicine, Psychology
    Journal of psychiatric practice
  • 2022
Six lessons can be learned from the pivotal registration trials for sublingual dexmedetomidine (SLD) for the treatment of agitation in individuals with bipolar disorder or schizophrenia: (1) Knowing

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