Journey Medical announces data from bioavailability study of DFD-29 vs Solodyn

Journey Medical announced data from a comparative bioavailability study of DFD-29 vs. Solodyn. DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy’s Laboratories Ltd. The data were presented at the 43rd Annual Fall Clinical Dermatology Conference taking place in Las Vegas, NV. “The results of this bioavailability study successfully demonstrate that the systemic exposure of minocycline with DFD-29 was significantly lower than that of Solodyn,” said Srinivas Sidgiddi, M.D., Vice President, Research & Development of Journey Medical. “We’re also encouraged by DFD-29’s safety profile demonstrated throughout our ongoing development program.” Data highlights include: Bioavailability of minocycline was significantly lower after a single dose of DFD-29 under fasting and fed conditions vs. Solodyn following a single dose under fasting conditions. Food intake had no impact on maximum concentration of minocycline from DFD-29 but may delay absorption and may slightly increase exposure. Treatment-emergent adverse events were mostly mild, the most common being headache. No serious adverse events were reported in the study. Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, stated, “We continue to be encouraged by the growing body of clinical research evaluating DFD-29. Given the previously reported positive results from our two Phase 3 clinical trials of DFD-29, we anticipate submitting a New Drug Application to the FDA by the end of this year. If approved, DFD-29 will be the lowest-dose minocycline on the market and may create a paradigm shift in how rosacea is treated in the millions of patients suffering from this condition.”