Trial Profile
A Phase 3, Randomized, Double-blind, Placebo-controlled, 12-month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants with Chronic Cough (PN027)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 24 Dec 2023
Price :
$35
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At a glance
- Drugs Gefapixant (Primary)
- Indications Cough
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms COUGH-1
- Sponsors Merck Sharp & Dohme; Merck Sharp & Dohme Corp.
- 20 Dec 2023 According to a Merck and Co media release, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding New Drug Application (NDA) for gefapixant. The FDA concluded that NDA application did not meet substantial evidence of effectiveness for treating RCC and UCC. The CRL was not related to the safety of gefapixant. Merck is reviewing the FDA's feedback to determine next steps.
- 21 Jul 2023 According to a Merck AG media release, based on the data of COUGH-1 and COUGH-2 clinical trials, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of gefapixant for the treatment for adults with refractory or unexplained chronic cough. The CHMP's recommendation will now be reviewed by the European Commission (EC) for marketing authorization in the European Union (EU) and a final decision is expected later this year.
- 01 Aug 2022 Results of pooled analysis of two studies (COUGH-1 & COUGH-2) assessing efficacy of gefapixant in predefined subgroups based on sex, region, age, cough duration, cough severity, cough frequency, and diagnosis, published in the Lung.