Menlo Therapeutics’ (NASDAQ:MNLO) ZILXI received FDA approval for the treatment of inflammatory lesions of rosacea in adults.
The company noted that ZILXI, a minocycline topical foam, is the first minocycline product of any kind to be approved by the FDA for use in rosacea.
The approval is based on two clinical trials that assessed a total of 1,522 patients. ZILXI met both co-primary endpoints in each clinical trial, demonstrating statistically significant improvements in inflammatory lesion count and Investigator Global Assessment treatment success.
“This approval is welcome news for clinicians and patients who seek novel options for this difficult-to-treat skin disorder,” David Domzalski, Menlo’s CEO, said in a statement.
“ZILXI is a potential turning point in rosacea treatment, providing millions of people with a new treatment option that is well tolerated and effective,” he added.