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Naldemedine: First Global Approval

Drugs volume 77, pages 923–927 (2017)Cite this article

Abstract

Naldemedine (Symproic®) is an orally active µ-opioid receptor antagonist being developed by Shionogi & Co., Ltd. that has been approved in the USA and Japan for the treatment of opioid-induced constipation. The drug inhibits peripheral µ-opioid receptors such as those present in the gastrointestinal tract and has minimal or no effect on central opioid activity. This article summarizes the milestones in the development of naldemedine leading to its first global approval in the USA for the treatment of opioid-induced constipation in patients with chronic non-cancer pain.

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. A. Markham is a contracted employee of Adis, Springer SBM.

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    Anthony Markham

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  1. Anthony Markham
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Correspondence to Anthony Markham.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Markham, A. Naldemedine: First Global Approval. Drugs 77, 923–927 (2017). https://doi.org/10.1007/s40265-017-0750-0

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Keywords

  • Placebo Recipient
  • Naltrexone
  • Moxifloxacin
  • Oxycodone
  • Spontaneous Bowel Movement