The Merck pharmaceutical company has revealed that Gefapixant, an experimental drug designed to overcome chronic cough, still has a way to go before the US market. As part of his announcement, Merck said he had received a complete response (CRL) from the FDA which was looking for more details about the efficacy of the drug, which meant the body had refused to approve the current treatment.
FDA wants to know more
Gefapixant is a selective P2X3 receptor antagonist, Merck said, is still investigated at this time. Oral medicines, should it get approval in the US, will be the nation’s first medicine designed to treat chronic cough (UCC) that cannot be explained and cough chronic refractories (RCC) in adults.
Merck has targeted approval in the US for a while. The pharmaceutical company previously sent the new GeFapixant (NDA) drug application to the FDA, ultimately received response to receiving from the agency in March 2021 (through Merck). Fast forward for almost a year and the FDA finally sent Merck the complete response letter requested more info about Gefapixant.
In his letter, Merck said that the current review, the FDA requested more information about the efficacy of Gefapixant. Pharmaceutical companies say FDA letters are not related to drug security profiles. It took time for Merck to review CRL and return to the agency.
Approved in Japan
Although the US FDA refused to approve the current drug, Gefapixant received a warmer response in Japan, where the Ministry of Health, workers and the welfare of the nation made the decision to approve treatment with the name Lyfnua. That the agreement includes the GeFapixant tablet with a dose of 45 mg which is intended to treat adults suffering from UCC or RCC.
On September 8, 2020, Merck announced the results of two-phase 3 trials involving treating chronic cough with two 45mg Gefapixant tablets every day compared to placebo. The trial, called cough-1 and cough-2, reveals a decrease in the frequency of cough “statistically significantly” over a 24-hour period compared to placebo on the 12 weeks and 24 weeks.
In a statement about findings, the Merck Research Laboratories’ Dr. Roy Baynes said, “The two trials meet the primary endpoint at a dose of 45 mg twice a day, significantly reducing the frequency of cough in this patient, and we thank you for the opportunity to share. Data with the scientific community.”