DFD-29 shows positive comparative results for treatment of papulopustular rosacea
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Journey Medical Corporation announced that DFD-29 has demonstrated low systemic exposure in the treatment of papulopustular rosacea based on an ongoing phase 3 study, according to a company press release.
“What Journey Medical is bringing, and what we’re hoping that the phase 3 study demonstrates, is a significantly superior drug that is going to change the paradigm of how to treat these rosacea patients,” Claude Maraoui, cofounder, president and CEO of Journey Medical Corporation, told Healio.
The single-center, randomized, open-label, single-dose, three-treatment, crossover, comparative bioavailability study, which is near enrollment completion, compared DFD-29 (minocycline modified release capsules 40 mg) with Solodyn (minocycline modified release tablets 105 mg, Bausch).
According to the press release, the single oral dose was administered under fasting conditions to 24 healthy adults. During 30 days of examination, DFD-29 exhibited significantly lower systemic exposure compared with Solodyn. There were similar safety profiles between the two drugs, and researchers found that food did not affect the pharmacokinetics of DFD-29.
“If the phase 3 trial is positive, which is what we are anticipating, I think the whole model and the standard of care will really be revolutionized with the DFD-29 being introduced upon FDA approval,” Maraoui said.
The study, which is in collaboration with Dr. Reddy’s Laboratories, is at 96% enrollment completion. Journey Medical Corporation reports that it anticipates topline data from this study in the first half of 2023 along with the filing of a new drug application in the second half of the year.
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