New drug application submitted for Journey Medical’s rosacea candidate
Key takeaways:
- DFD-29 showed safety and efficacy in two phase 3 clinical rosacea trials.
- Significant improvements in IGA, total lesion count and erythema were recorded in the trials.
A new drug application has been submitted to the FDA for oral DFD-29 for the treatment of rosacea, Journey Medical announced in a press release.
In two phase 3 clinical trials, patients treated with DFD-29 (minocycline hydrochloride modified release capsules 40 mg) showed superior efficacy to those treated with both placebo and doxycycline 40 mg (Oracea, Galderma).
Journey used data from these studies to support the NDA.
“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,” Claude Maraoui, co-founder, president and CEO of Journey Medical, said in the release. “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 (redness) from rosacea.”
The two trials found significant improvements in both IGA and total inflammatory lesion count, as well as the secondary endpoints related to erythema.
DFD-29 is being developed in collaboration between Journey and Dr. Reddy’s Laboratories.