FDA accepts new drug application for DFD-29 for rosacea treatment

Key takeaways:

• DFD-29 minocycline hydrochloride modified release capsule 40 mg is under review as a treatment for rosacea.
• The FDA has set a PDUFA date of Nov. 4.

The FDA has accepted Journey Medical’s new drug application for oral DFD-29 for the treatment of rosacea, the company announced in a press release.

As Healio previously reported, Journey Medical submitted a new drug application for oral DFD-29 (minocycline hydrochloride modified release capsules 40 mg) for the treatment of rosacea in January. Yesterday, the FDA accepted the company’s application and set a PDUFA date of Nov. 4.

“We are pleased that the FDA has set a PDUFA date ... and we look forward to collaborating with the agency throughout the review process in order to bring this unique treatment option to patients suffering from rosacea,” Claude Maraoui, co-founder, president and CEO of Journey Medical, said in the release. “If approved, we believe that DFD-29 will be the only oral medication to address both inflammatory lesions and erythema (redness) from rosacea, and will be a preferred treatment option by physicians and their patients to address the condition.”

According to the release, the new drug application was supported by positive data from Journey Medical’s two DFD-29 phase 3 trials for the treatment of rosacea. Both trials achieved all co-primary and secondary endpoints by week 16 and none of the subjects experienced significant safety issues.

DFD-29’s IGA success and ability to reduce inflammatory lesion counts also outperformed both the current standard of care treatment, Oracea (doxycycline, Galderma) 40 mg capsules, and placebo.