Merck Reports the US FDA's Acceptance of NDA for Review of Gefapixant to Treat Refractory or Unexplained Chronic Cough
Shots:
- The NDA submission is based on two P-III studies (COUGH-1 & -2) involves assessing gefapixant (45/15mg- bid) vs PBO in 2-044 patients with RCC & UCC
- In both the studies- gefapixant resulted in the reduction of in 24hrs.-cough frequency @12 & 24wks respectively. Data were presented at ERS 2020
- Gefapixant is a selective P2X3 receptor antagonist for the potential treatment of refractory or unexplained chronic cough. The anticipated PDUFA date is Dec 21- 2021
Ref: Businesswire | Image: Merck
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