New medicine for rosacea! Foamix local antibiotic FMX103 (minocycline, 1.5% foam) has a strong effect and will be approved in June.

February 19, 2020 / BIOON / -- foamix pharmaceuticals is a professional pharmaceutical company headquartered in rehowort, Israel, which is committed to developing and commercializing new external therapies to meet the unmet needs in the field of dermatology treatment Recently, the company published the 2020 Nanhai beach dermatology seminar in Miami, published the comprehensive efficacy analysis of FMX103 (minocycline, 1.5% foam) in the treatment of 2 moderate to severe moderate to severe papular pustular rosacea (PPR) in adults with 2 key clinical trials Currently, the new drug application (NDA) of fmx103 for the treatment of moderate to severe papule pustular rosacea (PPR) in adults (18 years and over) is under review by the food and Drug Administration (FDA) FDA has designated the target date of PDUFA as June 2, 2020 Rosacea is a chronic skin disease, which can cause inflammatory lesions (pimples and pustules) on nose, cheek, chin and forehead It may cause social and psychological burden on patients, such as embarrassment, anxiety and low self-esteem, thus adversely affecting the quality of life Rosacea is most common in adults aged 30-50 In the United States, the disease affects more than 16 million people There is no cure for rosacea Mild rosacea is treated with local antibiotics (metronidazole, clindamycin and ivermectin), azelaic acid or tretinoin, while the main drugs for moderate to severe rosacea are oral antibiotics, such as doxycycline and tetracycline, and off label use of oral minocycline FMX103 is a topical external minocycline foam preparation developed by Foamix proprietary foam technology It can significantly reduce inflammatory lesions in patients with moderate to severe papular pustular rosacea in clinical research If approved, fmx103 has the potential to become the first topical minocycline product for rosacea treatment The highlights of the comprehensive analysis efficacy published at the meeting are summarized as follows: - the comprehensive efficacy analysis summarizes the data of two identical key phase III clinical trials (fx2016-11 and fx2016-12), and compares fmx103 with excipients In the two studies, 1522 patients (1009 in fmx103 group and 513 in excipient group) were treated once a day for 12 weeks ——A comprehensive analysis of the two studies showed that fmx103 showed statistically significant benefits at two common primary endpoints compared with excipients: (1) from baseline to week 12, the number of inflammatory lesions in the fmx103 treatment group was significantly lower than that in the excipient group (- 18.0 vs-14.9, P < 0.001) (2) At the 12th week of treatment, according to the investigator's overall evaluation (IGA) of treatment success (IGA score 0 or 1), a higher proportion of patients in the fmx103 treatment group achieved a IgA score of 0 (complete removal of lesions) or 1 (almost complete removal of lesions) and at least a level 2 improvement (50.6% vs 41.0%, P < 0.001) (3) In all the supportive sensitivity analyses, fmx103 was found to have a statistical advantage over excipients at two common primary endpoints ——In the subgroup analysis of disease severity, fmx103 showed statistically significant efficacy over excipients in both baseline severity groups: IgA 3 ("moderate") and IgA 4 ("severe") ——In each study, subjects assessed as having severe papule and pustular rosacea (IGA 4) at baseline: (1) from baseline to week 12, the reduction rate of inflammatory lesions in the fmx103 group was significantly higher than that in the vehicle group (- 26.0 vs-15.1, P < 0.001) (2) At the 12th week, the proportion of subjects in fmx103 group who got IgA treatment was significantly higher than that in excipient group (36.8% vs 14.9%, P = 0.003) ——The comprehensive efficacy analysis further proved that as early as the 4th week, fmx103 showed therapeutic effect on disease improvement Original source: foamix announcements integrated efficiency results from the fmx103 1.5% topical microcycline foam phase 3 program for rosacea