Journey Medical Corporation announced positive topline results from the two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea® in Rosacea-1 (“MVOR-1”) and Minocycline Versus Oracea in Rosacea-2 (“MVOR-2”), evaluating Minocycline Hydrochloride Modified Release Capsules, 40 mg (“DFD-29”) for the treatment of moderate-to-severe papulopustular rosacea in adults. DFD-29 is being developed to treat rosacea in collaboration with Dr. Reddy’s Laboratories Ltd.
Subjects in the MVOR-1 and MVOR-2 Phase 3 clinical trials were randomized in a 3:3:2 ratio to treatment with DFD-29, Doxycycline Capsules, 40 mg (“Oracea”) or placebo once daily for 16 weeks. The primary objective of both studies was to evaluate the safety and efficacy of DFD-29 compared to a placebo for the treatment of papulopustular rosacea. The secondary objective was to evaluate the safety and efficacy of DFD-29 compared to Oracea. Both clinical trials achieved the co-primary and all secondary endpoints, which compared the efficacy of DFD-29 to Oracea and placebo for the treatment of rosacea. The proportion of subjects achieving Investigator’s Global Assessment (“IGA”) treatment success in the DFD-29 group was statistically superior to those in Oracea and placebo groups. Additionally, the reduction in the total inflammatory lesion count from baseline to week 16 in the DFD-29 group was statistically superior to Oracea and placebo groups. There were no major safety issues and no serious adverse events related to study products in both MVOR-1 and MVOR-2 trials. The number of treatment-emergent adverse events (“TEAEs”) and their severity were similar between the treatment groups. The number of TEAEs related to study products was also similar between the groups.
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