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Merck & Co recently announced that the U.
The NDA will be discussed at an upcoming advisory committee meeting, and a date has not yet been determined.
Dr.
gefapixant NDA is based on the results of 2 key phase III clinical trials (COUGH-1, COUGH-2).
The results showed that the study reached the primary endpoint: compared with the placebo group, the frequency of coughing in the gefapixant treatment group at a dose of 45 mg twice a day during the 12th week (COUGH-1 study) and 24th week (the COUGH-2 study) ( Using 24-hour recording to objectively measure the number of coughs per hour) has a statistically significant reduction.
The specific data are as follows: (1) In the COUGH-1 study, in the 12th week of treatment, compared with the placebo group, the frequency of coughing in the group treated with gefapixant at a dose of 45 mg twice a day was significantly reduced by 18.
The secondary endpoint supports the main observations of the study.
In 2 studies, the safety and tolerability of gefapixant are consistent with previous research reports.
It is estimated that 5%-10% of adults worldwide suffer from chronic cough.
Considering the huge unmet needs of these patients, the results of the COUGH-1 and COUGH-2 studies are very encouraging, indicating that gefapixant has the potential to provide a new treatment option for patient groups struggling with the burden of this disease.
Original source: US FDA Accepts Merck's Gefapixant New Drug application for Review
