The US Food and Drug Administration (FDA) has approved Journey Medical’s Emrosi (minocycline hydrochloride extended release capsules 40mg) to treat inflammatory lesions of rosacea in adults.

Affecting more than 16 million people in the US, rosacea is a long-term inflammatory skin condition that causes deep facial redness, acne-like inflammatory lesions and visible blood vessels in the face.

The FDA’s decision on Emrosi, which Journey developed in collaboration with Dr Reddy’s Laboratories, was based on positive results from two 16-week phase 3 rosacea trials, which met all co-primary and secondary endpoints, with no significant safety issues observed.

The drug demonstrated statistically significant superiority over both Galderma’s standard-of-care Oracea 40mg capsules and placebo for Investigator’s Global Assessment treatment success as well as the reduction in total inflammatory lesion count.

Beyond its physical manifestations, psychological impact has been recognised as a significant part of rosacea, with 90% of patients in National Rosacea Society surveys reporting that the condition had lowered their self-confidence and self-esteem, and 41% noting that it had caused them to avoid public contact or cancel social engagements.

Additionally, among those with severe symptoms, 88% said the disorder had adversely affected their professional interactions, and 51% reported missing work because of their condition.

Claude Maraoui, co-founder, president and chief executive officer of Journey Medical, said: “Rosacea is a difficult-to-treat skin condition and based on the favourable results from our phase 3 clinical trials, Emrosi has potential to become the best-in-class oral medication to treat the condition.

“Our seasoned dermatology-focused sales force is now preparing for a successful launch and to establish Emrosi as a new standard of care in the treatment of rosacea.”

The company anticipates that an initial supply of the drug will be available late in the first quarter or early in the second quarter of 2025.