Merck’s MF/F Phase III study data presented at AAAAI annual meeting

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).

The second study presented was a randomized, multicenter, double-blind, placebo-controlled clinical trial that assessed the safety and efficacy of MF/F 200/10mcg administered via MDI twice daily in patients 12 years of age and older with persistent asthma previously treated with medium 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 200mcg twice daily prior to study randomization. A total of 781 patients were then randomized to 26 weeks of double-blind, twice daily treatment with: MF/F (200/10mcg), mometasone furoate MDI (200mcg), 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 200/10mcg twice daily increased time-to-first severe exacerbation and decreased the proportion of patients experiencing severe exacerbations over the course of the study; 30 percent of patients treated with MF/F 200/10mcg twice daily experienced severe exacerbations versus 54 percent of formoterol-treated patients (p<0.001).

Compared with mometasone furoate, patients receiving MF/F 200/10mcg twice daily showed improvements in lung function. Results showed the mean FEV1 AUC (0-12h) over baseline at week 12 was 3.11 liter-hours in patients receiving MF/F 200/10mcg twice daily compared with 1.30 liter-hours in patients receiving mometasone furoate 200mcg twice daily (p<0.001).

The most common treatment emergent adverse reactions occurring in the MF/F 200/10mcg twice daily group were nasopharyngitis (6.3 percent), upper respiratory tract infection (5.8 percent), headache (4.7 percent), pharyngitis (4.2 percent), pharyngolaryngeal pain (3.1 percent), pyrexia (3.1 percent), viral infection (3.1 percent), bronchitis (2.6 percent), influenza (2.6 percent), rhinitis (2.6 percent), and sinusitis (2.6 percent).

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