Merck has announced results of two Phase 3 clinical studies of Dulera mometasone furoate/formoterol fumarate inhalation aerosol for the treatment of COPD that show statistically significant improvement in lung function in most of the combinations studied and document the incidence of treatment-related adverse events for two dosage strengths. Dulera is approved in the US for the treatment of asthma patients ages 12 and older, and Merck has filed a supplemental NDA for Dulera for the treatment of COPD.
The two studies each evaluated efficacy and safety for two dose strengths, with moderate-to-severe COPD patients receiving either 200 mcg/10 mcg or 400 mcg/10 mcg daily for 26-week periods. Both studies showed significant improvement in lung function for both dose strengths compared to mometasone alone, and one of the studies showed statistically significant improvement in lung function for Dulera compared to formoterol alone. At the thirteen week mark, Dulera demonstrated significant improvement in lung function versus placebo.
After completion of the 26-week study, researchers randomly selected three quarters of the patients randomized to active treatment to participate in a 26-week treatment safety extension. According to Merck, “At 26 weeks, the pooled incidence of treatment-related adverse events for the DULERA 400 mcg/10 mcg, DULERA 200 mcg/10 mcg, mometasone furoate 400 mcg, formoterol 10 mcg, and placebo groups was 7.2 percent, 4.9 percent, 8.0 percent, 7.5 percent, and 5.4 percent, respectively.” Exposure-adjusted rates of serious adverse events for the same groups were 16.8 percent, 12.1 percent, 16.6 percent and 16.2 percent events/100 subject-years, respectively.
No statistically significant difference “in the incidence or nature of adverse events” was observed at 52 weeks compared to 26 weeks. “The majority of treatment-related adverse events were mild to moderate in severity,” notes Merck, with the most common adverse events being oral fungal infection and cataracts and lenticular opacity.
Merck Research Laboratories Executive Director, Global Scientific Affairs, James E. Fish commented, “These investigational studies confirm Merck’s commitment to research in respiratory diseases. We’re excited to see these data for this investigational use of DULERA presented and discussed at CHEST.”
The company quotes a study investigator Dennis E. Doherty, Professor of Medicine in the Division of Pulmonary, Critical Care and Sleep Medicine at the University of Kentucky as saying, “This is the first presentation of data from these Phase III investigational studies evaluating the efficacy and safety of Dulera in patients 40 years and older with moderate to very severe COPD. It’s important that the scientific community continue evaluating potential treatment options for our patients with COPD.”
Read the Merck press release.
