NDA Accepted for Investigational Minocycline Capsule for Rosacea

The Food and Drug Administration (FDA) has accepted the New Drug Application for DFD-29 (minocycline hydrochloride modified release capsules, 40mg) for the treatment of adults with inflammatory lesions and erythema of rosacea.

The application is supported by data from two multicenter, randomized, double-blind, active-comparator, placebo-controlled phase 3 trials (ClinicalTrials.gov Identifier: MVOR-1 [NCT05296629], MVOR-2 [NCT05343455]) that assessed the efficacy and safety of DFD-29 in adults with moderate to severe papulopustular rosacea. Study participants were randomly assigned 3:3:2 to receive DFD-29 (40mg), doxycycline 40mg (Oracea), or placebo once daily for 16 weeks. 

The coprimary endpoints for both trials were the proportion of patients with Investigator’s Global Assessment (IGA) treatment success of Grade 0 or 1 at week 16 with at least a 2-grade reduction and the total inflammatory lesion count reduction at week 16.

In MVOR-1, 65% of patients treated with DFD-29 achieved IGA success at week 16 compared with 46.1% of those in the doxycycline 40mg arm (P =.007) and 31.2% of those in the placebo arm (P <.001). Treatment with DFD-29 also achieved a mean reduction of 21.3 inflammatory lesions compared with mean reductions of 15.9 lesions in the doxycycline 40mg arm and 12.2 lesions in the placebo arm (both P <.001).

In MVOR-2, 60.1% of patients treated with DFD-29 achieved IGA success at week 16 compared with 31.4% of those in the doxycycline 40mg arm and 26.8% of those in the placebo arm (both P <.001). Treatment with DFD-29 also achieved a mean reduction of 18.4 inflammatory lesions compared with mean reductions of 14.9 lesions in the doxycycline 40mg arm and 11.1 lesions in the placebo arm (both P <.001).

Additionally, both trials met all secondary endpoints, including percentage change in total inflammatory lesion count, IGA treatment success, total inflammatory lesion count reduction, clinician’s erythema assessment, and change in dermatology life quality index (DLQI) score. There were no significant safety issues reported.

A Prescription Drug User Fee Act (PDUFA) target date of November 4, 2024 has been assigned for this application.