Application for Orally Administered
Selective P2X3 Receptor Antagonist Based on Findings from Two Phase
3 Trials in Patients with Refractory or Unexplained Chronic
Cough
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, announced today that the U.S. Food and Drug Administration
(FDA) has accepted for review the company’s New Drug Application
(NDA) for gefapixant, an investigational, orally administered,
selective P2X3 receptor antagonist, for the treatment of refractory
chronic cough (RCC) or unexplained chronic cough (UCC) in adults.
This application for gefapixant will be discussed at an upcoming
advisory committee meeting. No date has been set yet. The FDA has
set a Prescription Drug User Fee Act (PDUFA), or target action
date, of Dec. 21, 2021.
“This submission underscores our commitment to help patients
with refractory or unexplained chronic cough who currently have
limited treatment options,” said Dr. Roy Baynes, senior vice
president and head of global clinical development, chief medical
officer, Merck Research Laboratories. “If approved by the FDA,
gefapixant would be the first medicine approved specifically to
help these patients, and we look forward to participating in the
advisory committee meeting and working with the FDA as they review
our application.”
The NDA is based on results from the COUGH-1 and COUGH-2
clinical trials, which are the first companion Phase 3 studies ever
conducted in patients with RCC, a cough that persists despite
appropriate treatment of underlying conditions, or UCC, a cough
where the underlying cause cannot be identified despite a thorough
evaluation. Data from COUGH-1 and COUGH-2 were presented at the
virtual European Respiratory Society (ERS) International Congress
2020.
About the COUGH-1 and COUGH-2 Trials
COUGH-1 (NCT03449134) and COUGH-2 (NCT03449147) are Phase 3
multinational, randomized, double-blind, placebo-controlled studies
evaluating the efficacy and safety of gefapixant in reducing cough
frequency in adult participants with refractory chronic cough (RCC)
or unexplained chronic cough (UCC). A total of 2,044 participants
were treated in COUGH-1 (n=730) and COUGH-2 (n=1,314). In both
studies, patients were randomly selected to receive one of the
following: gefapixant 45 mg twice daily, gefapixant 15 mg twice
daily, or placebo. The primary efficacy outcomes measure for
COUGH-1 and COUGH-2 were 24-hour cough frequency at week 12 and
24-hour cough frequency at week 24, respectively, measured using an
ambulatory digital audio recording device. Secondary endpoints in
both trials included awake coughs per hour and percentage of
participants with a greater than 1.3-point increase from baseline
in the Leicester Cough Questionnaire (LCQ) total score. COUGH-1 had
a 12-week treatment period and a 40-week extension period, while
COUGH-2 had a 24-week treatment period and a 28-week extension
period.
About Gefapixant
Gefapixant is an investigational, orally administered, selective
P2X3 receptor antagonist, for the potential treatment of refractory
or unexplained chronic cough. P2X3 receptors are one of the
receptor types found on sensory nerve fibers, predominantly C
fibers, in the airway lining. Chemical stimuli, including adenosine
triphosphate (ATP), can be released from airway lining cells due to
airway inflammation, irritation and mechanical stress/injury.
Binding of extracellular ATP to P2X3 receptors on C fibers in the
airway can be sensed as a signal of potential damage, creating an
action potential, which may initiate coughing. The inhibition of
binding of extracellular ATP to P2X3 receptors is thought to reduce
sensory nerve activation and, subsequently, cough.
About Chronic Cough
The prevalence of chronic cough (a cough lasting more than 8
weeks) is estimated to be approximately 5% of adults in the U.S. In
a subset of these cases, patients either do not respond to
treatment of underlying conditions (such as asthma or
gastroesophageal reflux), known as refractory chronic cough (RCC),
or they have no identifiable underlying condition despite a
thorough evaluation, known as unexplained chronic cough (UCC).
There are currently no approved therapies for the treatment of RCC
or UCC.
About Merck
For 130 years, Merck, known as MSD outside of the United States
and Canada, has been inventing for life, bringing forward medicines
and vaccines for many of the world’s most challenging diseases in
pursuit of our mission to save and improve lives. We demonstrate
our commitment to patients and population health by increasing
access to health care through far-reaching policies, programs and
partnerships. Today, Merck continues to be at the forefront of
research to prevent and treat diseases that threaten people and
animals – including cancer, infectious diseases such as HIV and
Ebola, and emerging animal diseases – as we aspire to be the
premier research-intensive biopharmaceutical company in the world.
For more information, visit www.merck.com and connect with us on
Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of the global outbreak of novel coronavirus disease
(COVID-19); the impact of pharmaceutical industry regulation and
health care legislation in the United States and internationally;
global trends toward health care cost containment; technological
advances, new products and patents attained by competitors;
challenges inherent in new product development, including obtaining
regulatory approval; the company’s ability to accurately predict
future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign
risk; dependence on the effectiveness of the company’s patents and
other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2020
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
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