FDA

ER formulation of minocycline approved for rosacea

November 6, 2024

Brand name: Emrosi

Generic name: minocycline hydrochloride ER

Manufacturer: Journey Medical

Approval date: November 4, 2024

Emrosi (minocycline hydrochloride extended-release capsules) is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults.

Note: To reduce the development of drug-resistant bacteria, Emrosi should be used only as indicated.

Efficacy

Efficacy of Emrosi was evaluated in 2 randomized, double-blind, active- and placebo-controlled phase 3 trials (MVOR-1 [NCT05296629] and MVOR-2 [NCT05343455]) involving adults with moderate to severe papulopustular rosacea (N=653). Study participants were randomly assigned to receive Emrosi 40 mg, doxycycline 40 mg, or placebo once daily for 16 weeks.

Participants were required to have an inflammatory lesion count (papules and pustules) in the range of 15 to 60 lesions and an Investigator’s Global Assessment (IGA) score of 3 (“moderate”) or 4 (“severe”) at baseline. Coprimary endpoints in both trials were the proportion of patients with IGA treatment success (defined as IGA score of grade 0 [clear] or 1 [near clear] with ≥2-grade reduction from baseline), and the absolute change from baseline in total inflammatory lesion counts at week 16.

Mean age of participants was 49 years. At baseline, participants had a mean inflammatory lesion count of 25 (range, 15-58), 88% were scored as moderate (IGA=3), and 12% were scored as severe (IGA=4).

MVOR-1

Rates of IGA treatment success at 16 weeks:

• Emrosi: 65%
• doxycycline: 46%
• placebo: 31%

Mean absolute change from baseline in inflammatory lesion counts:

• Emrosi: -20.6
• doxycycline: -15.6
• placebo: -11.4

MVOR-2

Rates of IGA treatment success at 16 weeks:

• Emrosi: 60%
• doxycycline: 31%
• placebo: 27%

Mean absolute change from baseline in inflammatory lesion counts:

• Emrosi: -18.1
• doxycycline: -14.6
• placebo: -11.2

Safety

The most commonly observed adverse reaction (≥1%) in clinical trials was dyspepsia.

Recommended dose

The recommended dosage of Emrosi is 40 mg PO once daily.

Source:

Emrosi Pharmaceuticals. (2024). Emrosi: Prescribing information. https://emrosi.com/wp-content/uploads/2024/11/Emrosi-PI.pdf

Journey Medical Corporation. (2024, November 4). Journey Medical Corporation Announces U.S. FDA Approval of Emrosi (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the Treatment of Rosacea. [Press release]. https://ir.journeymedicalcorp.com/new-events/press-releases/detail/75/journey-medical-corporation-announces-u-s-fda-approval-of