‘Another arrow to the quiver for physicians’: FDA approves Emrosi for rosacea
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Key takeaways:
- Previously known as DFD-29, Emrosi is the product name for minocycline hydrochloride extended release capsules 40 mg.
- The approval is supported by two phase 3 trials.
The FDA has approved Emrosi for the treatment of rosacea in adults, Journey Medical Corporation announced in a press release.
“For many of the millions of patients diagnosed with rosacea, current treatments are not providing sufficient results,” Claude Maraoui, co-founder, president and CEO of Journey Medical, told Healio. “We believe Emrosi offers a new and compelling option for physicians to prescribe to their rosacea patients backed by the superior results that we generated in our clinical trials.”
Developed in collaboration with Dr. Reddy’s Laboratories and previously known as DFD-29, Emrosi is a 40 mg minocycline hydrochloride extended release capsule for the treatment of this inflammatory skin condition.
“The National Rosacea Society is pleased that an important new therapeutic option will soon be available to people with rosacea,” Andrew Huff, president and executive director of the National Rosacea Society, told Healio. “The approval of Emrosi adds another arrow to the quiver for physicians targeting their patients’ papulopustular rosacea and may be of special interest to patients concerned about antibiotic resistance because of its narrow spectrum of antibiotic activity.”
The approval was supported by positive data from two phase 3 clinical trials which demonstrated Emrosi’s superiority over placebo and the current standard of care treatment, Oracea (doxycycline, Galderma) 40 mg capsules. After 16 weeks of treatment, patients taking Emrosi saw greater improvements in their IGA scores and greater reductions in their total inflammatory lesion counts vs. placebo and Oracea.
According to the release, Journey Medical is finalizing the manufacturing of Emrosi and anticipates releasing its initial supply to the U.S. market in the first or early second quarter of 2025.