Drug Candidate for Chronic Cough Rejected by FDA Panel
FDA advisors told the agency that the current evidence does not support approval of gefapixant for chronic cough, a condition where no approved therapy exists. On Friday, members of the Pulmonary-Allergy Drugs Advisory Committee voted 12-1 that the small reductions in cough frequency demonstrated in phase III trials of the P2X3 receptor antagonist do not […]
Chronic Cough Drug Shows Some Benefit, but Taste-Related Events an Issue
MILAN — Twice-daily doses of the oral P2X3 receptor antagonist gefapixant may improve refractory or unexplained chronic cough, but at the cost of adverse events, a meta-analysis and systematic review found. Moderate-certainty evidence indicated that a 45-mg dose led to a small (17.6%, 95% CI 10.6-24.0) decrease in awake cough frequency, a small (16.0%, 95% […]