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Journey Medical Corporation Announces DFD-29 Data Presented at 44th Fall Clinical Dermatology Conference
Poster Presented on Dermal and Systemic Pharmacokinetics of Oral DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) versus Oral Doxycycline
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[{"type":"text","content":"Poster Presented on Dermal and Systemic Pharmacokinetics of Oral DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) versus Oral Doxycycline 40 mg Capsules (Oracea®) in Healthy Subjects With its modified-release formulation, DFD-29 (40 mg) provides higher dermal concentration than doxycycline from Day 1 onward at a similar dose, expected to translate into a clinically meaningful impact for treating patients with rosacea New Drug Application for DFD-29 under review by FDA with PDUFA goal date of November 4, 2024 SCOTTSDALE, Ariz., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions, today presented data assessing the dermal and systemic pharmacokinetics (PK) of oral DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) versus oral Doxycycline 40 mg capsules (Oracea®) in healthy subjects at the 44th Fall Clinical Dermatology Conference that is taking place October 24-27, 2024, in Las Vegas, NV. DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy’s Laboratories Ltd. Claude Maraoui, Co-Founder, President, and Chief Executive Officer of Journey Medical, stated, “Based on the robust safety and efficacy data seen throughout all our clinical trials, we believe DFD-29 can change the treatment landscape for the millions of patients suffering from rosacea. We submitted a New Drug Application to the U.S. Food and Drug Administration for DFD-29 earlier this year and look forward to the upcoming PDUFA date of November 4, 2024. If approved, DFD-29 has the potential to be the lowest fixed-dose minocycline and the best-in-class therapy for rosacea patients.” This randomized, open-label, single-center, parallel-group study evaluated the systemic and dermal PK of once-daily administration of oral DFD-29 40 mg capsules versus oral doxycycline 40 mg for 21 days in healthy adult volunteers. Plasma PK parameters (Cmax & AUC) were similar on Day 1 and Day 21 for minocycline (DFD-29), but doxycycline showed accumulation in the plasma with a significant increase in PK parameters from Day 1 to Day 21. Mean dermal Cmax and AUC for minocycline (DFD-29) reached maxi...