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A Phase 3 Study to Evaluate Orvepitant for the Treatment of Refractory Chronic Cough

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Trial Profile

A Phase 3 Study to Evaluate Orvepitant for the Treatment of Refractory Chronic Cough

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 12 Jun 2019

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At a glance

  • Drugs Orvepitant (Primary)
  • Indications Cough
  • Focus Registrational; Therapeutic Use
  • Sponsors NeRRe Therapeutics

Most Recent Events

  • 12 Jun 2019 New trial record
  • 07 Jun 2019 According to a NeRRe Therapeutics media release, phase 2b findings (VOLCANO-2) support further development of orvepitant in refractory chronic cough and meetings with the FDA and EMA are planned for Q4 2019 to discuss next steps.
  • 07 Jun 2019 According to a NeRRe Therapeutics media release, an important observation from the phase 2b study (VOLCANO-2: the cough frequency signal was less variable in those patients with higher cough frequency at baseline, allowing a clear separation from placebo to be seen with the 30 mg once daily dose of Orvepitant on all efficacy parameters, including cough frequency) will be incorporated in the design of this phase 3 study, thereby maximising probability of success.

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