The FDA has approved minocycline hydrochloride extended-release capsules (40 mg; Emrosi), formerly referred to as DFD-29, for the treatment of inflammatory lesions of rosacea in adults, according to a release by developer Journey Medical.1
“With approval from the FDA, Journey Medical is proud to deliver Emrosi, a unique treatment option for the millions of patients in the US suffering from rosacea,” said Claude Maraoui, co-founder, president, and chief executive officer of Journey Medical, in the release.1 “Rosacea is a difficult-to-treat skin condition and based on the favorable results from our phase 3 clinical trials, Emrosi has potential to become the best-in-class oral medication to treat the condition.”
About MVOR-1
Trial Name: A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea. (MVOR-1)
Clinicaltrials.gov Identifier: NCT05296629
Sponsor: Journey Medical Corporation
Summary: This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks.
The approval of minocycline hydrochloride extended-release capsules is supported by positive data from Journey Medical’s two phase 3 clinical trials for the treatment of rosacea, MVOR-1 (NCT05296629) and MVOR-2 (NCT05343455).2 Participants completed the 16-week treatment with no significant adverse effects and the most common adverse event was dyspepsia.
Further, minocycline hydrochloride extended-release capsules were more effective than both the current standard treatment, Oracea 40 mg capsules, and a placebo in both studies. This was demonstrated by a higher success rate as assessed by the Investigator’s Global Assessment and a greater reduction in the total number of inflammatory lesions.
About MVOR-2
Trial Name: A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)
Clinicaltrials.gov Identifier: NCT05343455
Sponsor: Journey Medical Corporation
Summary: This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks. Of the 320 subjects, approximately 160 subjects are planned to be enrolled at 15 sites in the US, while the remaining subjects are to be enrolled at 14 sites in the EU.
“Emrosi showed great efficacy and tolerability in the pivotal clinical trials, and we are tremendously grateful to the patients, physicians, investigators, and site coordinators who participated and contributed to this important approval milestone,” said Srinivas Sidgiddi, MD, vice president, research and development at Journey Medical, in the release.1
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Journey Medical is currently finalizing the production of minocycline hydrochloride extended-release capsules for the US market. The company expects initial supplies to be available late in the first quarter or early in the second quarter of 2024, and the company plans to commercialize the therapy in the US through its dermatology-focused commercial organization.
Rosacea is a chronic skin condition characterized by recurring inflammation. Common symptoms include deep facial redness, acne-like inflammatory lesions, and spider veins. The National Rosacea Society estimates that over 16 million Americans and 415 million people globally are affected by the condition.3
Additional data from The National Rosacea Society reveals that over 90% of patients with rosacea reported a decrease in self-confidence and self-esteem due to their condition. Further, 41% stated that they had avoided social interactions or canceled plans because of their condition.3 To address these challenges and offer a new therapeutic option for the patient population, Journey Medical intends to establish minocycline hydrochloride extended-release capsules as the new oral standard of care.1
READ MORE: Dermatology Resource Center
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