Efficacy and Safety of Nadifloxacin for Bacterial Skin Infections: Results from Clinical and Post-Marketing Studies

Abstract

IntroductionSkin and soft tissue infections involve microbial invasion of the skin and underlying soft tissues and are estimated to affect 7–10% of hospitalized patients worldwide. Nadifloxacin, a topical fluoroquinolone, has been shown to be effective against aerobic Gram-negative, Gram-positive (including MRSA and coagulase-negative staphylococci), and anaerobic bacteria. However, there is paucity of data comparing efficacy and safety of 1% nadifloxacin with other anti-bacterials for skin infections in Indian patients.MethodsThis article presents the results of one post-marketing surveillance (PMS) and three randomized, open, non-blinded, multi-centric clinical studies that compared nadifloxacin with mupirocin and framycetin, and nadifloxacin with fusidic acid. Patients in India, aged from 1 to 65 years old, suffering from mild to moderate bacterial skin infections including impetigo, secondarily infected wounds, folliculitis, infected atopic dermatitis, and furunculosis were randomly allocated to three treatment groups within the studies. Efficacy was assessed by the evaluation of symptoms of erythema, exudation, swelling, pruritus, crusting, pain and tenderness in all the studies.ResultsA total of 272 subjects were enrolled in the study and subjects were randomly assigned to one of the three treatment groups; 92 in the nadifloxacin group, 90 in the mupirocin group, and 90 in the framycetin group. A significant reduction in the mean scores for bacterial infection symptoms in the nadifloxacin groups was observed when compared to mupirocin, framycetin and fusidic acid groups. Both physician and patients rated nadifloxacin as excellent (complete remission of symptoms) on a 4-point scale in the studies. No adverse events (AEs) were reported in the clinical studies. In the PMS, only two patients (of 329, 0.6%) reported AEs including burning and itching, one in each patient that had resolved at the time of reporting.ConclusionNadifloxacin, a fluoroquinolone, is a new alternative topical agent in the treatment of bacterial skin infection with minimal AEs.Electronic supplementary materialThe online version of this article (doi:10.1007/s13555-014-0062-1) contains supplementary material, which is available to authorized users.

Perspectives in acne therapy: an analytical review (in Russian only)

“…Интересны исследования надифлоксацина -антибактериального средства для местного применения из группы фторхинолонов, активного в отношении аэроб ных грамположительных, грамотрицательных бактерий и анаэробов, находящихся на поверхности кожи [78,79]. Еще в 1991 г. в исследованиях [80], проводимых японскими учеными, была доказана эффективность надифлоксацина в отношении P. acnes.…”

“…Еще в 1991 г. в исследованиях [80], проводимых японскими учеными, была доказана эффективность надифлоксацина в отношении P. acnes. Надифлоксацин в форме 1% крема при лечении инфекций кожи по эффективности превосходит мупироцин, фрамицетин и фузидовую кислоту, а также сравним с 4% гелем эритромицина в отношении акне легкой и средней степени [79,81]. Данные исследования эффективности фиксированной комбинации 1% крема надифлоксацина и 0,1% геля адапалена (Индия) у пациентов, страдающих акне легкой и средней степени, продемонстрировали хороший результат в виде снижения количества воспалительных и невоспалительных элементов.…”

An evaluation of safety and efficacy of nadifloxacin 1% ointment versus mupirocin 1% ointment in Indian children with skin and soft tissue infection

“…Inhibition of this enzyme leads to bactericidal activity of nadifloxacin. 8 Nadifloxacin, a topical fluoroquinolone, has been shown to be effective against aerobic Gram-negative, Grampositive (including MRSA and coagulase-negative Staphylococci), and anaerobic bacteria. 8 However, there is a paucity of data comparing efficacy and safety of nadifloxacin with other antibacterials for treatment of skin infections especially in pediatric population in India.…”

“…8 Nadifloxacin, a topical fluoroquinolone, has been shown to be effective against aerobic Gram-negative, Grampositive (including MRSA and coagulase-negative Staphylococci), and anaerobic bacteria. 8 However, there is a paucity of data comparing efficacy and safety of nadifloxacin with other antibacterials for treatment of skin infections especially in pediatric population in India. Therefore this study was carried out to evaluate the efficacy and tolerability of nadifloxacin 1% ointment vs mupirocin 1% ointment in pediatric patients with SSTI.…”

Simple development and validation of RP-HPLC and TLC- densitometric methods for the simultaneous determination of nadifloxacine and mometasone furoate in their binary mixture

“…Nadifloxacine (ND), chemically (RS)-7-fluoro-8-(4hydroxypiperidin-1-yl)-12-methyl-4-oxo-1azatricyclo[7.3.1.0]trideca-2,5,7,9(13)-tetraene-3-carboxylic acid ( Figure 1A), is considered the first potent topical fluoroquinolone for treatment of acne vulgaris and skin infections [1]. In addition, it has been shown to be effective against aerobic Gram-negative, Gram-positive antibacterial drug [2]. Mometasone furoate (MF), a glucocorticoid, chemically 9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16trimethyl-3-oxo- 6,7,8,11,12,14,15,16octahydrocyclopenta[a]phenanthren-17-yl] furan-2-carboxylate ( Figure 1B), is a corticosteroid drug, the anti-inflammatory actions of corticosteroids are thought to involve phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.…”