Xepi (ozenoxacin) / Maruho, Cipher, Ferrer International - LARVOL DELTA

Ozenoxacin 1% in Pediatric and Adult Patients with Impetigo: A Meta-Analysis of Randomized Trials. (PubMed, J Clin Med) - " A systematic review and meta-analysis of randomized controlled trials (RCTs) comparing ozenoxacin 1% with placebo or mupirocin was conducted. Given the low heterogeneity observed, these findings support the clinical use of ozenoxacin for impetigo management. Future large-scale RCTs and direct comparative studies are warranted to further validate its therapeutic benefits."

Journal • Retrospective data • Review • Dermatology • Infectious Disease • Pediatrics

Ozenoxacin-Induced Contact Dermatitis With Tolerance to Ciprofloxacin. (PubMed, J Investig Allergol Clin Immunol) - No abstract available

Journal • Contact Dermatitis • Dermatitis • Dermatology • Immunology

Ecthyma secondary to varicella (EADV 2024) - "Patient was diagnosed and treated with Acyclovir for varicella 10 days prior to current lesions...Treatment included injectable Amoxicillin, Ceftriaxone, Vancomycin and Linezolid, potassium permanganate compresses and Ozenoxacin 1% cream... Factors associated with complications in varicella include topical, systemic, and inhaled steroids, immunosuppressants, NSAIDs, old-age, HIV, atopic dermatitis and low income. Although varicella complications were thought to be immune status dependent, immunocompetent children can be affected. In contrast to varicella gangrenosum which develops within 24-48 hours, secondary bacterial infections occur 10-14 days after an episode of varicella."

Atopic Dermatitis • Dermatitis • Dermatology • Human Immunodeficiency Virus • Immunology • Varicella Zoster

Ozenoxacin suppresses sebum production by inhibiting mTORC1 activation in differentiated hamster sebocytes. (PubMed, J Dermatol) - "Interestingly, nadifloxacin, but not clindamycin, exhibited a similar suppression of sebum production, albeit with lesser potency compared with ozenoxacin. Notably, it decreased the amount of TG on the skin surface. The results provide novel insights into the sebum-inhibitory properties of ozenoxacin, indicating its potential efficacy in controlling microbial growth and regulating sebum production for acne management."

Journal • Acne Vulgaris • Dermatology • SCD

In vitro activity of ozenoxacin against Staphylococcus aureus and Streptococcus pyogenes clinical isolates recovered in a worldwide multicentre study (2020-2022). (PubMed, JAC Antimicrob Resist) - "The most active comparators against S. aureus were retapamulin (MIC90 = 0.12 mg/L), fusidic acid (MIC90 = 0.25 mg/L) and mupirocin (MIC90 = 0.5 mg/L); and against S. pyogenes were retapamulin (MIC90 = 0.03 mg/L), clindamycin (MIC90 = 0.12 mg/L) and mupirocin (MIC90 = 0.25 mg/L). On the other hand, ozenoxacin had similar activity in ciprofloxacin-susceptible and resistant S. pyogenes isolates. Ozenoxacin is a potent antimicrobial agent of topic use against Gram-positive bacteria causing SSTI, including MRSA isolates non-susceptible to ciprofloxacin."

Journal • Preclinical • Infectious Disease

QbD Based Formulation Development and Optimisation of Ozenoxacin Topical Nano-Emulgel and Efficacy Evaluation Using Impetigo Mice Model. (PubMed, AAPS PharmSciTech) - "The systematic application of QbD principles facilitated the successful development and optimization of a Ozenoxacin Nano-Emulsion. Optimised Ozenoxacin Nano-Emulgel can be considered as an effective alternative and found to be stable at least for 6 months at 40 °C / 75% RH and 30 °C / 75% RH."

Journal • Preclinical • Dermatology

Formulation and optimisation of Ozenoxacin topical nano-emulgel including a comprehensive methodology to qualify and validate the critical parameters of an in-vitro release test method and ex-vivo permeation test. (PubMed, Drug Dev Ind Pharm) - "Results confirmed that IVRT and Reversed Phase - High Performance Liquid Chromatographic techniques were validated as per regulatory guidelines. In-vitro, ex-vivo drug release and skin retention from the optimized nano-emulgel formulation was comparatively higher (∼1.5 times) than that from the innovator (OZANEXTM) formulation. Based on these results, Ozenoxacin nano-emulgel can be considered an effective alternative and was found to be stable at 40 °C/75% RH and 30 °C/75% RH storage condition for 6 months."

Journal • Preclinical

Identification, characterisation and in silico ADMET prediction of ozenoxacin and its degradation products using high-performance liquid chromatography-photodiode array and liquid chromatography-quadrupole time-of-flight-tandem mass spectrometry. (PubMed, Rapid Commun Mass Spectrom) - "The drug was found to be stable in neutral, acidic, basic and oxidative degradation conditions with hydrogen peroxide. Liquid chromatography-electrospray ionisation-quadrupole time-of-flight-tandem mass spectrometry- was employed in positive ionisation mode to analyse both the drug and the mass of the identified DP. The mechanism and the pathway of mass fragmentation have been proposed. The developed method was accurate, repeatable, linear and selective for further research. The ADMET Predictor software was applied to predict the in silico toxicity of the drugs and its DPs as well as their physicochemical characteristics."

Journal • Dermatology

Single-center, prospective, and observational study on the management and treatment of impetigo in a pediatric population. (PubMed, Eur Rev Med Pharmacol Sci) - "Topical ozenoxacin has strong efficacy in treating impetigo in pediatric patients. Ozenoxacin's clinical and microbiological rapid onset of response led to consider this antibiotic a novel efficacy option for the treatment of impetigo."

Journal • Observational data • Dermatology • Infectious Disease • Pediatrics

"Tak til @MD5120 for gaven, samt tak til @ProfJLundgren og @IgumRasmussen for at tage sig tid til at skrive bogen, som giver et godt indblik i hele pandemien. Indeholder gode indlæg omkring mange af de emner der blev diskuteret intens for 1-2 år siden. Kan varmt anbefales👍" (@MartinJuhl2)

Co-infection of Pseudomonas aeruginosa and Achromobacter xylosoxidans in green nail syndrome treated with ozenoxacin (WCD 2023) - "Ozenoxacin, the first nonfluorinated quinolone, could be a safe, topical treatment in case of MDR nail infections. Further studies are required to evaluate clinical isolation from nail infections and the co-presence of P. aeruginosa and A. xylosoxidans"

Cystic Fibrosis • Dermatology • Fibrosis • Immunology • Infectious Disease

Paradoxical hidradenitis suppurativa in a 16 year old patient with Crohn’s disease treated with Adalimumab (WCD 2023) - "Adalimumab discontinuation, and topical Ozenoxacin 1% three times a day were followed by a significant improvement of skin lesions...Further studies are needed to determine the most appropriate treatment choice toward ongoing biologic therapy in patients with CD 1) Salvatori S, Marafini I, Monteleone G. Paradoxical hidradenitis suppurativa in Crohn's disease patients receiving infliximab: a case report and review of literature. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e1046-e1050"

Clinical • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Hidradenitis Suppurativa • Immunology • Inflammation • Inflammatory Bowel Disease

Retrospective Analysis of the Real-World Use of Topical Antimicrobials in the Paediatric Population with Impetigo in Italy: Focus on the Role of Ozenoxacin 1% Cream. (PubMed, Children (Basel)) - "In contrast, the rate of treatment failure was similar. Very few adverse reactions were identified."

Journal • Real-world • Real-world evidence • Retrospective data • Dermatology • Dermatopathology • Pediatrics

Ozenoxacin effectiveness in hidradenitis suppurativa (EHSF 2023) - "As systemic tetracyclines and quinolones have also demonstrated potent anti-inflammatory effect, they are widely accepted in the treatment of the hidradenitis suppurativa...According to other simultaneous treatment, they were included in three groups: no other treatment (naive), biological therapy (adalimumab, secukinumab and guselkumab) and oral antibiotic...Hurley stage, localization of the lesions and previous use of topical clindamycin were also included...Our study suggests that this non-fluorinated quinolone could decreased pain and suppuration of the lesions in patients with hidradenitis suppurativa specially those with mild Hurley stages and with lack of previous use of antibiotics. Although further studies are required, we propose the use of topical ozenoxacin in patients with hidradenitis suppurativa as useful alternative therapy in these patients."

Dermatology • Gastrointestinal Disorder • Hidradenitis Suppurativa • Immunology • Infectious Disease • Inflammation • Pain

Disproportionality analysis of quinolone safety in children using data from the FDA adverse event reporting system (FAERS). (PubMed, Front Pediatr) - "Most FAERS reports associated with ciprofloxacin (N = 2,706) followed by levofloxacin (N = 1,191), moxifloxacin (N = 375), oflaxacin (N = 245) and ozenoxacin (N = 187). Generally, the findings of this study are compatible with AEs recorded in package inserts. The unexpected signals of ozenoxacin justify active vigilance by clinicians and timely monitoring by pharmacovigilance experts."

Adverse events • Journal • Asthma • Cardiovascular • CNS Disorders • Epilepsy • Febrile Neutropenia • Gastrointestinal Disorder • Hematological Disorders • Hypotension • Immunology • Infectious Disease • Mental Retardation • Musculoskeletal Diseases • Neutropenia • Pediatrics • Psychiatry • Pulmonary Disease • Respiratory Diseases • Rheumatology

Clinical and economic consequences of ozenoxacin vs. other topical antibiotics for the treatment of impetigo: a real-life study in Spain. (PubMed, Glob Reg Health Technol Assess) - "Impetigo is a common dermatological paediatric infection that can be treated with topical antibiotics: the common are mupirocin (MUP), fusidic acid (FA) and, most recently, ozenoxacin (OZ). The percentage of patients ending treatment after 2 weeks was 87.6% (OZ) vs. 83.2% (MUP) vs. 82.4% (FA); p<0.001; complication rates were 1.8% (OZ), 3.3% (MUP) and 3.2% (FA), p<0.001; mean costs were €158 (OZ), €265 (MUP) and €287 (FA), p<0.001. OZ is a cost-effective and dominant alternative for the treatment of impetigo."

Journal • Dermatology • Infectious Disease • Pediatrics

"Esse xepi é uma vergonha, mais um brasileiro canalha" (@fernando_lissa)

Antimicrobial activity of ozenoxacin and other antimicrobials against Staphylococcus aureus strains isolated from clinical skin specimens in Japan in 2019 and 2020. (PubMed, J Infect Chemother) - "The minimum inhibitory concentrations (MIC) of OZNX for MSSA and MRSA were 0.12 and 0.25 μg/mL, respectively, indicating that OZNX exhibited the same or stronger antibacterial activity than that of the other antimicrobials tested, such as nadifloxacin, fucidic acid, and gentamicin. Notably, a low MIC of OZNX was observed even for strains with reduced susceptibility to nadifloxacin, a similar quinolone-based topical antimicrobial. OZNX is a highly potent antimicrobial used in Japan for superficial skin infections caused by S. aureus, such as impetigo contagiosa and related diseases."

Journal • Dermatology • Infectious Disease

New therapeutic applications of ozenoxacin in superficial skin infections. (PubMed, Dermatol Reports) - "Ozenoxacin 10mg/g is a topical quinolone that has shown high activity on strains of S. aureus, S. pyogenes and other Gram-positive bacteria sensitive and resistant to methicillin, other quinolones, mupirocin and fusidic acid. No adverse reaction was reported during treatment. Given the achieved effectiveness, safety, and adherence of the treatment, we believe that pediatricians should consider this topical antibiotic for the treatment of other superficial skin infections, without limiting its use to non-bullous impetigo."

Journal • Dermatology • Infectious Disease • Pediatrics

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Dermatology

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Clinical

Identification of Trovafloxacin, Ozanimod, and Ozenoxacin as potent c-Myc G-quadruplex stabilizers to suppress c-Myc transcription and myeloma growth. (PubMed, Mol Inform) - "Further experiments showed that Trovafloxacin, Ozanimod, and Ozenoxacin decreased c-Myc mRNA level obviously and downregulated c-Myc expression significantly. In summary, compounds Trovafloxacin, Ozanimod, and Ozenoxacin might be regarded as new c-Myc G4 stabilizers for the treatment of c-Myc related cancers in the future."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology • MYC

Uptake of Ozenoxacin and Other Quinolones in Gram-Positive Bacteria. (PubMed, Int J Mol Sci) - "We investigated the accumulation of ozenoxacin (OZN), moxifloxacin (MOX), levofloxacin (LVX), and ciprofloxacin (CIP) into the bacterial cells of 5 species, including Staphylococcus aureus (SA4-149), Staphylococcus epidermidis (SEP7602), Streptococcus pyogenes (SPY165), Streptococcus agalactiae (SAG146), and Enterococcus faecium (EF897) previously characterized.The concentration of quinolone uptake was estimated by agar disc-diffusion bioassay. OZN intracellular concentration was significantly higher than that of MOX, LVX and CIP. All of these features may explain the higher in vitro activity of OZN compared to the other tested quinolones."

Journal • Infectious Disease

Pediatric impetigo: an expert panel opinion about its main controversies. (PubMed, J Chemother) - "Each controversy has been revised thus giving practical issues for an easy use in clinical practice. Based on clinical experts' opinion, local epidemiology and literature review this article offers practical suggestions for the management of pediatric impetigo trying to reduce uncertainty in this setting of care."

Clinical • Journal • Dermatology • Infectious Disease • Pediatrics

Emerging Treatment Strategies for Impetigo in Endemic and Nonendemic Settings: A Systematic Review. (PubMed, Clin Ther) - "This review highlights the limited research into new drugs used for the treatment of impetigo in endemic and nonendemic settings. Limited recent evidence supports the use of topical ozenoxacin or retapamulin for impetigo treatment in nonendemic settings, whereas systemic antibiotics and the mass drug administration strategy have evidence for use in endemic settings. Given the troubling increase in resistance to existing treatments, there is a clear need to ensure the judicious use of antibiotics and to develop new treatments and alternative strategies; this is particularly important in endemic settings. PROSPERO identifier: CRD42020173042."

Journal • Review • Dermatology