FDA Approves DFD-29 for Treatment of Adults With Rosacea-Related Inflammatory Lesions

Updated November 5, 2024 at 11:14 AM.

The FDA approved minocycline hydrochloride extended-release capsules (DFD-29, Emrosi; Journey Medical) for the treatment of adults with inflammatory lesions caused by rosacea. The approval is supported by positive data from 2 phase 3 clinical trials, MVOR-1 (NCT05296629) and MVOR-2 (NCT05343455), both of which assessed DFD-29 as a treatment option for patients 18 years and older with rosacea.¹

Rosacea is a chronic, inflammatory, relapsing skin condition most frequently seen in adults between 30 and 50 years of age. The condition most commonly presents with symptoms such as facial redness, inflammatory lesions that appear similar to acne (papules and pustules), and spider veins (telangiectasia). The National Rosacea Society estimates that the condition affects over 16 million Americans and as many as 415 million individuals worldwide. Additionally, approximately 90% of patients with rosacea reported that their condition lowered their self-confidence, 41% said they avoided public contact or cancelled social engagements, and among patients with severe symptoms, 88% and 51% said that their rosacea had negatively impacted their professional interactions and missed work, respectively.¹

“…Rosacea is a difficult to treat skin condition and based on the favorable results from our phase 3 clinical trials, [DFD-29] has potential to become the best-in-class oral medication to treat the condition. Our seasoned dermatology-focused sales force is now preparing for a successful launch and to establish [DFD-29] as a new standard of care in the treatment of rosacea,” Claude Maraoui, co-founder, president, and CEO of Journey Medical, said in a news release.¹

Both the MVOR-1 (NCT05296629) and MVOR-2 (NCT05343455) are 16-week, multicenter, randomized, parallel-group, double-blind, controlled phase 3 clinical trials. The trials enrolled about 320 participants with severe papulopustular rosacea who were at least 18 years of age. Patients were randomly assigned to receive 40-mg extended-release capsules of DFD-29, 40-mg capsules of the current standard of care treatment doxycycline (Oracea; CollaGenex Pharmaceuticals), or placebo.^2,3

For both trials, the primary end points were investigator’s global assessment (IGA) treatment success and total inflammatory lesion count reduction compared with placebo, both of which were assessed from baseline to week 16. Secondary end points included percentage change in total inflammatory lesion count (compared with doxycycline and placebo), IGA treatment success (compared with doxycycline), clinician’s erythema assessment (compared with placebo), and change in dermatology life quality index score (compared with placebo).^2,3

According to the news release, the phase 3 trials met all co-primary and secondary end points, and all participants completed the 16-week treatment duration without any significant safety issues. For both studies, DFD-29 showed statistically significant superiority compared with both placebo and doxycycline for IGA treatment success and reductions in total inflammatory lesion count.¹

An analysis from June 2023⁴ demonstrated that in the MVOR-1 and MVOR-2 studies, about 65.0% and 60.1% of participants in the DFD-29 groups, respectively, achieved IGA success, whereas the rate was lower in the doxycycline and placebo groups. (MVOR-1: 46.1% and 31.2%; MVOR-2: 31.4% and 26.8%). Additionally, the DFD-29 groups showed a greater mean reduction of lesions (MVOR-1: 21.3; MVOR-2: 18.4) compared with the doxycycline (MVOR-1: 15.9; MVOR-2: 12.2) and placebo (MVOR-1: 14.9; MVOR-2: 11.1) groups.⁴ Further, for patients receiving treatment with DFD-29, the most common adverse event reported was dyspepsia.¹

“[DFD-29] showed great efficacy and tolerability in the pivotal clinical trials, and we are tremendously grateful to the patients, physicians, investigators, and site coordinators who participated and contributed to this important approval milestone,” Srinivas Sidgiddi, MD, vice president of research and development at Journey Medical, said in the news release.¹

REFERENCES

1. Journal Medical Corporation. Journey Medical Corporation Announces U.S. FDA Approval of Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the Treatment of Rosacea. News release. November 4, 2024. Accessed November 5, 2024. https://ir.journeymedicalcorp.com/new-events/press-releases/detail/75/journey-medical-corporation-announces-u-s-fda-approval-of

2. A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea. (MVOR-1). ClinicalTrials.gov identifier: NCT05296629. Updated August 2, 2023. Accessed November 5, 2024. https://clinicaltrials.gov/study/NCT05296629

3. A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2) (MVOR-2). ClincialTrials.gov identifier: NCT05343455. Updated August 2, 2023. Accessed November 5, 2024. https://clinicaltrials.gov/study/NCT05343455

4. BioSpace. Journey Medical Corporation Announces Positive Topline Results from its Two Phase 3 Clinical Trials (MVOR-1 and MVOR-2) Evaluating DFD-29 for the Treatment of Papulopustular Rosacea in Adults. News release. July 11, 2023. Accessed November 5, 2024. https://www.biospace.com/journey-medical-corporation-announces-positive-topline-results-from-its-two-phase-3-clinical-trials-mvor-1-and-mvor-2-evaluating-dfd-29-for-the-treatment-of-papulopustular-rosacea-in-adults