NCHR Provides Oral Testimony at the FDA Pulmonary Allergy Advisory Committee Meeting on Gefapixant

We appreciate the opportunity to provide oral testimony at the FDA Pulmonary Allergy Advisory Committee Meeting regarding the new drug approval of Gefapixant.

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

While Gefapixant represents a novel treatment for refractory or unexplained cough we are concerned that the benefits of the drug do not outweigh the risk of adverse events. The pooled COUGH 1 and 2 analyses showed that patients who took Gefapixant at 45mg BID experienced a 18.6% reduction in 24-hour cough frequency, however patients who received the placebo medication also reported a large reduction in 24-hour cough frequency at 17.4%.

Further, a pooled dose-response meta-analysis that included 9 randomized clinical trials and 2,980 patients showed that Gefapixant at 45mg BID only improved patient’s quality of life by 1 point on the Leicester Cough Questionnaire. Patients treated with Gefapixant at 45mg BID also experienced adverse taste-related events at a rate of 32% when compared with placebo and patients taking higher doses reported adverse taste-related events at a rate of 81%.

Together, these data show that there is a modest difference in cough frequency and improved quality of life with Gefapixant when compared to placebo which is of little clinical value. Thus, we conclude that Gefapixant does not adequately address the unmet need for treating patients with refractory or unexplained cough in terms of effectiveness or tolerability and appreciate the FDA Pulmonary Allergy Advisory Committee taking these data into consideration when making their decision.