Merck (MRK) Says Phase III Studies on DULERA(R) Showed Improved Lung Function, But No Statistical Significance
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Merck (NYSE: MRK) today announced results from two 26-week investigational Phase III clinical studies evaluating the efficacy and safety of two dose strengths of DULERA® (mometasone furoate and formoterol fumarate dihydrate) in adults 40 years and older with moderate to very severe chronic obstructive pulmonary disease (COPD). The two dose strengths evaluated in the studies were DULERA 100 mcg/5 mcg and DULERA 200 mcg/5 mcg, both administered as two inhalations twice daily (i.e. 200 mcg/10 mcg and 400 mcg/10 mcg, twice daily).
In both studies, DULERA 200 mcg/10 mcg and DULERA 400 mcg/10 mcg significantly improved lung function as measured by forced expiratory volume in one second (FEV1) area under the curve over 0-12 hours (AUC0−12hr) at Week 13 (one of the co-primary endpoints) compared to treatment with mometasone furoate 400 mcg (administered as two inhalations of mometasone furoate 200 mcg twice daily), the primary treatment comparison for this endpoint, or placebo alone.
In Study 1, DULERA 200 mcg/10 mcg and DULERA 400 mcg/10 mcg significantly improved AM predose FEV1 at Week 13 (the other co-primary endpoint) compared to treatment with formoterol 10 mcg (administered as two inhalations of formoterol 5 mcg twice daily), the primary treatment comparison for this endpoint, or placebo alone. In Study 2, DULERA 200 mcg/10 mcg and DULERA 400 mcg/10 mcg significantly improved AM predose FEV1 at Week 13 compared to treatment with placebo, but neither dose of DULERA reached statistical significance compared to treatment with formoterol 10 mcg.
The safety profile of DULERA in the maintenance treatment of COPD was also evaluated over the 26 week trials. Results of an additional 26-week extension of these studies, evaluating the drug’s safety profile over 52 weeks, were also presented. Data from these studies will be presented for the first time on Wednesday at CHEST 2011, the 77th annual meeting of the American College of Chest Physicians (ACCP), in Honolulu, Hawaii.
In both studies, DULERA 200 mcg/10 mcg and DULERA 400 mcg/10 mcg significantly improved lung function as measured by forced expiratory volume in one second (FEV1) area under the curve over 0-12 hours (AUC0−12hr) at Week 13 (one of the co-primary endpoints) compared to treatment with mometasone furoate 400 mcg (administered as two inhalations of mometasone furoate 200 mcg twice daily), the primary treatment comparison for this endpoint, or placebo alone.
In Study 1, DULERA 200 mcg/10 mcg and DULERA 400 mcg/10 mcg significantly improved AM predose FEV1 at Week 13 (the other co-primary endpoint) compared to treatment with formoterol 10 mcg (administered as two inhalations of formoterol 5 mcg twice daily), the primary treatment comparison for this endpoint, or placebo alone. In Study 2, DULERA 200 mcg/10 mcg and DULERA 400 mcg/10 mcg significantly improved AM predose FEV1 at Week 13 compared to treatment with placebo, but neither dose of DULERA reached statistical significance compared to treatment with formoterol 10 mcg.
The safety profile of DULERA in the maintenance treatment of COPD was also evaluated over the 26 week trials. Results of an additional 26-week extension of these studies, evaluating the drug’s safety profile over 52 weeks, were also presented. Data from these studies will be presented for the first time on Wednesday at CHEST 2011, the 77th annual meeting of the American College of Chest Physicians (ACCP), in Honolulu, Hawaii.
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