Journey’s oral minocycline product Emrosi significantly improves rosacea
Key takeaways:
- IGA success rates and lesion count reductions were higher in those treated with Emrosi vs. placebo or Oracea.
- Emrosi was approved by the FDA in November 2024 and launched by Journey Medical on March 24.
Patients with rosacea experienced improvement with Emrosi, an oral minocycline hydrochloride extended-release product, according to results from two phase 3 clinical trials.
“To bring minocycline back to relevance, especially for rosacea, was really exciting,” Neal Bhatia, MD, director of clinical dermatology at Therapeutics Clinical Research in San Diego, told Healio. “If you think historically about where minocycline as a molecule fits, it was used for decades at a 100 mg dose for rosacea. It was then purified into a 1.5% foam for rosacea, which still works well and is still on the market, but this dosage of systemic minocycline is dedicated to impacting the inflammatory cascade of cathelicidins and matrix metalloproteinases and neutrophils, all of the components that make rosacea roll downhill and without the concerns of safety from higher doses.”
The identical double-blind, parallel-group, active-comparator and placebo-controlled phase 3 MVOR-1 and MVOR-2 trials randomly assigned adult patients with moderate to severe papulopustular rosacea to receive once-daily Emrosi 40 mg (10 mg immediate release and 30 mg extended release, Journey Medical Corporation), Oracea 40 mg (doxycycline 30 mg immediate release and 10 mg extended release, Galderma) or placebo for 16 weeks.
IGA success, defined as at least a two-grade reduction from baseline and an IGA score of 0 or 1, and a reduction in total inflammatory lesion count compared with placebo were the studies’ primary efficacy end points.
Secondary endpoints included total inflammatory lesion count percentage change compared with placebo, IGA success rates and lesion counts compared with the active comparator and the proportion of patients with a two-grade or more reduction in Clinician’s Erythema Assessment (CEA) scores.
IGA success was achieved by 65% and 60.1% of patients in the respective Emrosi treatment groups, compared with 46.1% and 31.4% of those in the Oracea groups and 31.2% and 26.8% of those in the placebo groups, all of which were statistically significant improvements.
Those treated with Emrosi showed a mean lesion reduction of 21.3 in MVOR-1 and 18 in MVOR-2, compared with 15.8 and 14.9 in the Oracea groups and 12.1 and 11.1 in the placebo groups, respectively.
Additionally, 31.7% and 24.5% of those in the two Emrosi treatment groups experienced a two-grade or greater reduction in CEA score, compared with 13.8% and 12% of those in the placebo groups, which was a significantly greater percentage.
“Not only does it prove the efficacy of minocycline, it is safe for the long-term per the study data. Patients were really happy. Nobody wanted to give it up,” Bhatia said. “It’s exciting to have minocycline back in dermatology because we need to keep all the tools we can in the toolbox. Really, the take-home message is to understand the process of inflammation and how to counter that with the mechanism of therapy. That will lead to the best outcomes, especially given the superiority over doxycycline at similar doses. The issues of hyperpigmentation and lupus-like syndrome were also not a concern given the low cumulative dose as we saw in the trials.”
Treatment-emergent adverse events (TEAEs) were similar in the three treatment groups, with 26.8% of patients in MVOR-1 and 37.2% of those in MVOR-2 reporting at least one adverse event.
No patients in the Emrosi groups discontinued treatment because of TEAEs, whereas 1.7% of those in the Oracea group and 1.3% of those in the placebo group did so in MVOR-1. In MVOR-2, 1.6% in the Emrosi group, 0% of the Oracea group and 2.4% of the placebo group discontinued treatment because of adverse events.
Dyspepsia was the most common adverse events in patients treated with Emrosi.
The FDA approved Emrosi for the treatment of inflammatory lesions of rosacea in November 2024, and the company launched the product on March 24.
“Rosacea is a challenging condition that affects millions, and Emrosi, the lowest dose oral minocycline on the market, delivers significantly superior clinical outcomes for rosacea compared to Oracea and placebo, while maintaining a comparable safety profile, as demonstrated in clinical trials,” Claude Maraoui, cofounder, president and CEO of Journey Medical, said in a press release.
Reference:
- Journey Medical Corporation announces publication in the Journal of the American Medical Association - Dermatology of the phase 3 clinical trial results of Emrosi (DFD-29) to treat rosacea. https://ir.journeymedicalcorp.com/new-events/press-releases/detail/79/journey-medical-corporation-announces-publication-in-the. Published March 5, 2025. Accessed March 21, 2025.
- Journey Medical Corporation launches Emrosi (40 mg minocycline hydrochloride modified-release capsules, 10 mg immediate release and 30 mg extended release) for the treatment of rosacea https://ir.journeymedicalcorp.com/new-events/press-releases/detail/82/journey-medical-corporation-launches-emrosi-40-mg. Published March 24, 2025. Accessed March 24, 2025.
For more information:
Neal Bhatia, MD, can be reached at bhatiaharbor@gmail.com.