Journey Medical has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for DFD-29 (minocycline hydrochloride modified release capsule) to treat inflammatory lesions and erythema (redness) of rosacea in adults.

Affecting approximately 16 million people in the US, rosacea is a long-term, inflammatory skin condition that causes small, red, pus-filled bumps, redness and visible blood vessels in the face.

There is currently no cure for rosacea, and treatment focuses on controlling symptoms with medicine, gentle skin care and avoiding things that cause flare-ups.

If approved by the FDA, DFD-29, which is being developed in collaboration with Dr Reddy’s Laboratories, has the potential to become the only oral, systemic therapy approved to address both erythema and inflammatory lesions associated with the condition.

The NDA is supported by two late-stage clinical trials, which achieved all co-primary and secondary endpoints and demonstrated no significant safety issues associated with DFD-29, with all patients completing the 16-week treatment.

In patients with rosacea, DFD-29 demonstrated statistical superiority over both the current standard-of-care treatment, Oracea (doxycycline) 40mg capsules, and placebo for Investigator’s Global Assessment treatment success as well as reduction in the total inflammatory lesion count.

On a secondary endpoint related to erythema assessment, DFD-29 showed a statistically significant reduction in Clinician’s Erythema Assessment compared to placebo.

Claude Maraoui, co-founder, president and chief executive officer of Journey Medical, said: “This NDA submission is a significant milestone for Journey Medical and we look forward to collaborating with the FDA during its review to bring DFD-29, a potentially differentiated, best-in-class oral rosacea treatment, one step closer to patients. 

“Based on the data seen in our pivotal trials, DFD-29 could fundamentally improve the treatment paradigm for patients suffering from both inflammatory lesions and erythema from rosacea.”