Efficacy of Oral DFD-29, a Low-Dose Minocycline Formulation, in Patients With Rosacea: A Pooled Analysis of Two Phase 3 Trials
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Keywords
Rosacea, Oral DFD-29, Efficacy, Pooled Analysis, Low-Dose Minocycline
Abstract
Background: A modified low-dose formulation of minocycline hydrochloride 40 mg (DFD-29) is now available in the United States as EmrosiTM (minocycline hydrochloride) for treating the inflammatory lesions of rosacea. In this pooled analysis, we evaluate the efficacy of DFD-29 compared to Oracea® (doxycycline 40 mg) and placebo in the two phase 3 trials.
Methods: This is a pooled analysis of 2 randomized, double-blind, active- and placebo-controlled, phase 3 clinical trials (MVOR-1 and MVOR-2) among adults aged ≥18 years with moderate-to-severe rosacea conducted in the US and Germany. Participants were randomized in a 3:3:2 ratio to oral DFD-29 (minocycline hydrochloride capsules) 40 mg, doxycycline 40 mg, or placebo once daily for 16 weeks. The coprimary efficacy endpoints were (1) the proportion of participants experiencing Investigator’s Global Assessment (IGA) treatment success with DFD-29 vs placebo and (2) reductions in total inflammatory lesion counts with DFD-29 vs placebo. Comparisons between DFD-29 and doxycycline were key secondary endpoints.
Results: In this pooled analysis of MVOR-1 (N = 323) and MVOR-2 (N = 330), a total of 653 participants (76.0% female) were randomized to DFD-29 (n = 245), doxycycline (n = 246), and placebo (n = 162). At baseline, most participants (88.4%) had moderate IGA scores and the mean total inflammatory lesion count was 24.9 (SD, 8.9). DFD-29 demonstrated superior efficacy in IGA success rates (62.7%) vs both placebo (28.2%; P<0.001) and doxycycline (39.0%; P<0.001). DFD-29 also showed superior efficacy in least-squares mean (LSM) reductions in total inflammatory lesion counts vs placebo (-19.2 [SD, 0.52] vs -11.3 [0.66]; P<0.001) and vs doxycycline (-19.0 [SD, 0.52] vs -14.8 [SD, 0.53]; P<0.001). DFD-29 was generally well tolerated, with no noteworthy differences in the frequency or severity of reported adverse events between groups.
Conclusion: This pooled analysis confirmed the superior efficacy of DFD-29 in the treatment of inflammatory lesions of rosacea versus both placebo and doxycycline 40 mg and demonstrated its favorable risk-benefit profile.
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