The U.S. Food and Drug Administration has approved Journey Medical’s Emrosi (minocycline hydrochloride) for the treatment of inflammatory rosacea in adults.
The extended-release capsules (40 mg) will be available late in the first quarter or early in the second quarter of 2025.
The approval was based on positive results from two 16-week Phase III clinical trials, during which Emrosi met all coprimary and secondary end points and showed significant superiority over both the current standard-of-care treatment (Oracea) and placebo for Investigator’s Global Assessment treatment success as well as reduction in total inflammatory lesion count. Additionally, participants experienced no significant safety issues.
“Rosacea is a difficult to treat skin condition, and based on the favorable results from our Phase III clinical trials, Emrosi has the potential to become the best-in-class oral medication to treat the condition,” Claude Maraoui, the cofounder, president, and CEO of Journey Medical, said in a statement.
“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.”
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FDA approves Emrosi for rosacea in adults (2024, November 13)
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The U.S. Food and Drug Administration has approved Journey Medical’s Emrosi (minocycline hydrochloride) for the treatment of inflammatory rosacea in adults. The extended-release capsules (40 mg) will be available late in the first quarter or early in the second quarter of 2025. The approval was based on positive results from two 16-week Phase III clinical trials, during which Emrosi met all coprimary and secondary end points and showed significant superiority over both the current standard-of-care treatment (Oracea) and placebo for Investigator’s Global Assessment treatment success as well as reduction in total inflammatory lesion count. Additionally, participants experienced no significant safety issues. “Rosacea is a difficult to treat skin condition, and based on the favorable results from our Phase III clinical trials, Emrosi has the potential to become the best-in-class oral medication to treat the condition,” Claude Maraoui, the cofounder, president, and CEO of Journey Medical, said in a statement. “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.” More information: Copyright © 2024 HealthDay. All rights reserved. Citation: This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no
More Information
FDA approves Emrosi for rosacea in adults (2024, November 13)
retrieved 13 November 2024
from
part may be reproduced without the written permission. The content is provided for information purposes only.
