Foamix to Announce Topline Results in Phase 2 Clinical Trial of FMX-103 Minocycline Topical Foam for Moderate-to-Severe Papulopustular Rosacea
This was a double-blind, randomized, placebo-controlled Phase 2 trial involving 233 patients who were enrolled in 18 sites throughout Germany. Patients were randomized to receive high dose FMX103 (3% minocycline foam), low dose FMX103 (1.5% minocycline foam) or vehicle foam over 12 weeks, followed up by a 4-week post-treatment evaluation. The primary endpoints are safety, tolerability and efficacy in the treatment of moderate-to-severe papulopustular rosacea.
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Papulopustular rosacea is a chronic skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead. It can create psychosocial burdens, such as embarrassment, anxiety and low self-esteem that adversely affect quality of life. Rosacea is most frequently seen in adults between 30 and 50 years of age. Although the exact root cause of rosacea remains unknown, both genetic and environmental factors are thought to have an impact on causing this disease.
There is no known cure for rosacea. Mild papulopustular rosacea is treated by topical antimicrobials (metronidazole, clindamycin, sulfacetamide-sulphur and ivermectine), azelaic acid or retinoids, while systemic antibiotics such as minocycline and doxycycline are the mainstay for the treatment of moderate-to-severe rosacea, often in combination with topical agents (Drugs (2014) 74:1457-1465).
Foamix is a specialty pharmaceutical company focused on the development and commercialization of proprietary, innovative and differentiated topical drugs for dermatological therapy.
Our clinical stage product candidates include FMX101, our novel minocycline foam for the treatment of moderate-to-severe acne, FMX102 for the treatment of impetigo, FMX103 for the treatment of moderate-to-severe rosacea, and FDX104, our doxycycline foam for the management of acne-like rash induced by EGFRI anticancer drugs.
In addition, we have development and license agreements relating to our technology with various pharmaceutical companies including
For more information, please visit www.foamixpharma.com.
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U.S. Investor Relations
LifeSci Advisors, LLC
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