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Gefapixant: First Approval.

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  • 1Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. dru@adis.com.

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Gefapixant, a novel P2X3 receptor antagonist, offers a new non-narcotic treatment for chronic cough. Its development milestones led to its recent marketing approval in Japan.

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Area of Science:

  • Pharmacology
  • Respiratory Medicine

Background:

  • Chronic cough, including refractory and unexplained types, significantly impacts quality of life.
  • Current treatments for chronic cough have limitations, necessitating novel therapeutic approaches.

Purpose of the Study:

  • To summarize the key development milestones of gefapixant, a selective P2X3 receptor antagonist.
  • To highlight the journey leading to the first marketing approval of gefapixant for chronic cough.

Main Methods:

  • Review of preclinical and clinical development data for gefapixant.
  • Analysis of regulatory submission and approval processes in key markets.

Main Results:

  • Gefapixant is a first-in-class, non-narcotic P2X3 receptor antagonist.
  • The drug has received marketing approval in Japan for refractory or unexplained chronic cough.
  • Regulatory submissions for gefapixant are underway in the EU and USA.

Conclusions:

  • Gefapixant represents a significant advancement in the treatment of chronic cough.
  • The development of gefapixant demonstrates a successful pathway for novel cough therapies.
  • The drug's approval marks a new therapeutic option for patients suffering from refractory or unexplained chronic cough.