Publication of clinical trial results

The information given below and the relevant links to the clinical data fulfil the requirements of Articles 71-73 of the Ordinance on Therapeutic Products (Therapeutic Products Ordinance, TPO). They supplement the information published in association with the Swiss marketing authorisation for the medicinal product.

LYFNUA®

Lyfnua® (Gefapixant), film-coated tablets, 45 mg

Swissmedic Zulassungsnummer: 68065

Date of Marketing Authorisation: 24-May-2022

Clinical Trials

1.  COUGH-1 (Protocol 027)

A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027) – ClinicalTrials.gov
NCT03449134

Publications:
McGarvey LP, Birring SS, Morice AH, Dicpinigaitis PV, Pavord ID, Schelfhout J, Nguyen AM, Li Q, Tzontcheva A, Iskold B, Green SA, Rosa C, Muccino DR, Smith JA; COUGH-1 and COUGH-2 Investigators. Efficacy and safety of gefapixant, a P2X(3) receptor antagonist, in refractory chronic cough and unexplained chronic cough (COUGH-1 and COUGH-2): results from two double-blind, randomised, parallel-group, placebo-controlled, phase 3 trials. Lancet. 2022 Mar 5;399(10328):909-923. doi: 10.1016/S0140-6736(21)02348-5.

2. COUGH-2 (Protocol 030)

A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030) – ClinicalTrials.gov
NCT03449147

Publications:
McGarvey LP, Birring SS, Morice AH, Dicpinigaitis PV, Pavord ID, Schelfhout J, Nguyen AM, Li Q, Tzontcheva A, Iskold B, Green SA, Rosa C, Muccino DR, Smith JA; COUGH-1 and COUGH-2 Investigators. Efficacy and safety of gefapixant, a P2X(3) receptor antagonist, in refractory chronic cough and unexplained chronic cough (COUGH-1 and COUGH-2): results from two double-blind, randomised, parallel-group, placebo-controlled, phase 3 trials. Lancet. 2022 Mar 5;399(10328):909-923. doi: 10.1016/S0140-6736(21)02348-5.

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