Data from two Phase III studies of Merck’s investigational fixed-dose
combinations of mometasone furoate and formoterol fumarate (MF/F) were
presented by researchers today in two poster presentations at the
American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting.
“Asthma is a common and complex disease. Results from these studies help
us to better understand the potential role of MF/F in asthma
management”
A New Drug Application (NDA) for MF/F is currently under review by the
U.S. Food and Drug Administration (FDA). Merck has also submitted a
Marketing Authorization Application (MAA) for MF/F to the European
Medicines Evaluation Agency (EMEA). MF/F combines the active ingredient
of an inhaled corticosteroid, ASMANEX® TWISTHALER®
(mometasone furoate inhalation powder), with the active ingredient of a
long-acting beta2-agonist, FORADIL® AEROLIZER®
(formoterol fumarate inhalation powder), administered via a single
metered-dose inhaler.
"Asthma is a common and complex disease. Results from these studies help
us to better understand the potential role of MF/F in asthma
management,” said Eli Meltzer, M.D., co-director of the Allergy & Asthma
Medical Group and Research Center in San Diego, California and study
investigator.
The first randomized, multicenter, double-blind, placebo-controlled
study assessed the efficacy and safety of MF/F 100/10mcg administered
via a metered dose inhaler (MDI) twice daily in patients 12 years of age
and older with persistent asthma previously treated with low dose
inhaled corticosteroids with or without a long-acting beta2-agonist.
Patients were assigned to a two-to-three week open-label, run-in period
with mometasone furoate MDI 100mcg twice daily prior to study
randomization. A total of 746 patients were then randomized to 26 weeks
of double-blind, twice daily treatment with: MF/F (100/10mcg),
mometasone furoate MDI (100mcg), formoterol MDI (10mcg) or placebo.
The co-primary endpoints of the study were the comparison of MF/F versus
formoterol in time-to-first severe asthma exacerbation over 26 weeks and
the comparison of MF/F versus mometasone furoate in the week 12 area
under the concentration-time curve (AUC) over baseline for forced
expiratory volume in one second (FEV1), measured from 0 to 12
hours. In this study, a severe asthma exacerbation was defined as a
meaningful reduction in lung function or an occurrence of any clinical
deterioration of asthma resulting in emergency treatment,
hospitalization, or treatment with additional asthma medication that was
excluded from the clinical studies (such as an oral or systemic steroid).
Compared with formoterol, MF/F 100/10mcg twice daily increased
time-to-first severe exacerbation and decreased the proportion of
patients experiencing severe exacerbations over the course of the study;
16.5 percent of patients treated with MF/F 100/10mcg twice daily
experienced severe exacerbations versus 44.7 percent of
formoterol-treated patients (p<0.001).
Compared with mometasone furoate, patients receiving MF/F 100/10mcg
twice daily showed improvements in lung function. Results showed the
mean FEV1 AUC (0-12h) over baseline at week 12 was 4.00
liter-hours in patients receiving MF/F 100/10mcg twice daily compared
with 2.53 liter-hours in patients receiving mometasone furoate 100mcg
twice daily>
The most common treatment emergent adverse events occurring in the MF/F
100/10mcg twice daily group were nasopharyngitis (9.3 percent), headache
(6.6 percent) upper respiratory tract infection (5.5 percent),
pharyngolaryngeal pain (3.8 percent), and pharyngitis (2.7 percent).