New treatment option now available! TOUGH ON IMPETIGO GENTLE ON THE1 PATIENT Demonstrated efficacy and safety1 Home Efficacy Safety Convenience (ozenoxacin) is indicated for the topical treatment of impetigo in patients aged 2 months and older.1 References Summary
ozanex kills vs. inhibits bacteria 1 Dual bactericidal mechanism of action: 1 Prevents Dna replication and causes bacterial cell death Promotes higher bactericidal activity than other antibiotics Delivers efficacy against resistant strains (including mrsa) ozanex works fast 1 ozanex demonstrated rapid clinical response vs. placebo after just 5 days, reducing the impact of infection.* 1 Clinical Success (%) 100 90 80 70 60 50 40 30 20 10 0 Clinical success (end of therapy)* 2 Clinical Cure Criteria 34.8% 19.2% (n=155) Visit 3 (Day 6-7) Placebo (n=156) p = 0.003 clinical success at the end of therapy: Based on post-2010 fda assessment criteria which defines clinical success as clinical cure. adapted from Gropper, et al. 2 Clinical Success (%) 100 90 80 70 60 50 40 30 20 10 0 Clinical success (end of therapy)* 2 Clinical Cure Plus Improvement Criteria 86.3% 76.2% (n=153) Visit 3 (Day 6-7) Placebo (n=151) p=0.0276 a post-hoc analysis evaluated clinical cure + improvement as per previous clinical studies conducted in impetigo (i.e., less stringent criteria was used, similar to the earlier published clinical studies). 2 adapted from Gropper, et al. 2 * Randomized, multicentre placebo-controlled, parallel, blinded (double-blind for vs. placebo), superiority clinical study comparing vs. placebo cream and retapamulin ointment vs. placebo, in patients with a clinical diagnosis of nonbullous or bullous impetigo. The primary effi cacy endpoint was clinical response (success or failure) in the intention-to-treat group at the end of therapy (Visit 3; Day 6-7). 2 Home efficacy Safety convenience RefeRenceS SummaRy
demonstrated significantly higher microbiological response vs. placebo 1 Rapid and high microbiological response rate at Days 3-4 vs. placebo 1 70.8% vs. 38.2% p <0.0001 Consider the benefits of for fast healing. 1 has a proven safety profile 1 has an established safety profile and was well tolerated in patients as young as 2 months 1 Most frequently reported adverse events 1 Application site irritation Application site pruritus Affected <1% of patients Safety was evaluated in 458 patients with superficial skin infections 1 Randomized, double-blind, placebo-controlled study in patients with impetigo treated with (n=154) or placebo (n=152) for 5 days. Patients applied study drug to affected areas twice daily. 1 Microbiological success was defined as absence of the original pathogen(s) (Visit 1, baseline) from the culture of specimen from the baseline affected area (with or without the presence of any new microorganism(s)). 1 Home Efficacy Safety Convenience References Summary
ozanex offers convenient dosing 1 the only treatment for impetigo with twice-daily, 5-day dosing 1 apply a thin layer to the affected area twice daily for 5 days. Scabs do not have to be removed. ed. if no clinical response within 3 days, re-evaluate and consider alternate therapy. Reduce the duration of impetigo and its negative impact on loss of school and work days 4 kills bacteria fast #1 BId dosing may be more convenient for your patients and encourage adherence 1,3 Treatment requirements are changing with the increasing prevalence of antibiotic-resistant bacteria 7 other treatment courses are usually 7-10 days or longer vs. 5 days with ozanex. 1,4-6 other treatment courses require application 3X daily. 4-6 ozanex is a bactericidal that showed in vitro antibacterial activity against Staphylococcus aureus, including mrsa, Streptococcus pyogenes, and other gram-positive microorganisms. 1 # In a randomized, double-blind, placebo-controlled study in patients with impetigo, demonstrated signifi cantly higher microbiological and clinical response vs. placebo after just 5 days of therapy (58.5% vs. 36%, respectively, p<0.001). 1 Home efficacy Safety convenience RefeRenceS SummaRy
Safety Information 1 Indications and Clinical Use: (ozenoxacin) is indicated for the topical treatment of impetigo in patients aged 2 months and older. To reduce the development of drug-resistant bacteria and maintain the effectiveness of and other antibacterial drugs, should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Geriatrics ( 65 years of age): A limited number of subjects aged 65 years have been treated with in clinical trials. Pediatrics (<2 months of age): The safety and efficacy of in pediatric patients younger than 2 months of age has not been established. Contraindications: is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation. Warnings and Precautions: Do not ingest. There are very limited efficacy data in subjects with impetigo affecting more than 50 cm 2 total surface area. Safety and efficacy has not been established in subjects with impetigo affecting more than 100 cm 2 in total surface area. In patients <12 years: total surface area treated should be no more than 2% of the body surface area. Do not use on mucous membranes (oral, intranasal, or intravaginal). contains propylene glycol which may cause skin irritation. contains stearyl alcohol which may cause local skin reactions (e.g., contact dermatitis). contains benzoic acid which may be an irritant to skin, eyes and mucous membranes and may increase jaundice in pre-term and full-term jaundiced neonates because of its absorption through the skin. Do not use in the eyes. Discontinue in the event of sensitization or severe local irritation, and carefully wipe off cream. Prescribing in the absence of a proven or strongly suspected bacterial infection risks the development of drug-resistant bacteria. Prolonged use may result in overgrowth of non-susceptible microorganisms, including fungi. Pregnant Women: No studies with have been performed in pregnant women. No effects during pregnancy are anticipated since systemic exposure to ozenoxacin is negligible. Nursing Women: Avoid applying to the breast area to protect nursing infant from unintentional oral drug uptake. For more information: Please consult the product monograph at http://www.cipherpharma.com/products/dermatology for more information relating to adverse reactions, drug interactions, and dosing information, which have not been discussed in this piece. The product monograph is also available by calling Cipher Pharmaceuticals Inc. at 1-888-361-7207. References: 1. Cipher Pharmaceuticals Inc. Ozanex Product Monograph. May 11, 2017. 2. Gropper S, Albareda N, Chelius K, et al. Ozenoxacin 1% cream in the treatment of impetigo: a multicenter, randomized placebo- and retapamulin-controlled clinical trial. Future Microbiol 2014;9(9):1013-1023. 3. Bangert S, Levy M, Hebert AA. Bacterial resistance and impetigo treatment trends: a review. Ped Dermatol 2012;29(3):243-248. 4. GlaxoSmithKline Consumer Healthcare Inc. Bactroban Product Monograph. July 6, 2016. 5. LEO Pharma Inc. Fucidin Product Monograph. July 10, 2017. 6. Dillon HC. Topical and systemic therapy for pyodermas. Int J Dermatol 1980;19:443-451. 7. Hartman-Adams H, Banvard C, Juckett G. Impetigo: diagnosis and treatment. Am Fam Physician 2014;90(4):229-35. Cipher Pharmaceuticals Inc. 2345 Argentia Road, Suite 100A Mississauga, ON L5N 8K4 www.cipherpharma.com Ozanex is a trademark of Ferrer Internacional S.A. 2017 Cipher Pharmaceuticals Inc. All Rights Reserved. CIP-OZDAEN Home Efficacy Safety Convenience References Summary
TOUGH ON IMPETIGO GENTLE ON 1 THE PATIENT A new treatment option is now available KILLS vs. inhibits bacteria1 Bactericidal cream has demonstrated activity against Streptococcus pyogenes and Staphylococcus aureus, including methicillinresistant (MRSA) strains.1 Works FAST1 Overall therapeutic success seen after just 5 days, reducing the impact of infection**1 Proven SAFETY profile1 cream has an established safety profile and was well tolerated in patients as young as 2 months1 CONVENIENT dosing1 Twice a day for 5 days1 ** Results from two randomized, double-blind, placebo-controlled studies in adult and pediatric patients 2 months (n=362) with impetigo who were treated with or placebo for 5 days. Patients applied study drug to affected areas twice daily.1 Home Efficacy Safety Convenience References Summary