Unexplained Chronic Cough
FDA declines to approve gefapixant for chronic cough a second time
The FDA has issued a complete response letter declining to approve a new drug application for gefapixant as a treatment for adults with refractory or unexplained chronic cough, according to a press release from Merck.
Cough, cough, cough ... for 6 months!
A 35-year-old high school teacher presents with a chronic cough of 6 months’ duration. The cough is described as dry, irritating and persistent. He has tried every over-the-counter cough medicine that he could find to no avail.
FDA panel votes against gefapixant for unexplained chronic cough
In a 12-to-1 vote, the FDA’s Pulmonary-Allergy Drug Advisory Committee voted against approving gefapixant 45 mg tablets to treat adults with refractory or unexplained chronic cough.
Gefapixant yields modest improvements in refractory, unexplained chronic cough vs. placebo
Gefapixant only showed small effects vs. placebo on objective cough frequency, cough severity and quality of life among adults with refractory or unexplained chronic cough, according to results of a systematic review and meta-analysis.
Gefapixant shows long-term efficacy for treatment of chronic cough
A pooled analysis of the COUGH-1 and COUGH-2 trials demonstrated long-term efficacy of twice-daily gefapixant out to 52 weeks in patients with refractory or unexplained chronic cough, according to data presented at the CHEST Annual Meeting.
Gefapixant reduces cough frequency in refractory, unexplained chronic cough
Treatment with gefapixant, a P2X3 receptor antagonist reduced cough frequency and cough-related quality of life in patients with refractory or unexplained chronic cough, according to results of two phase 3 trials.