OTOVEL EFFICACY

POWER

OTOVEL significantly shortened time to cessation of otorrhea in clinical studies vs ciprofloxacin and fluocinolone acetonide alone1

  • OTOVEL® (ciprofloxacin and fluocinolone acetonide) was compared with its components in two randomized, double-blind, active-controlled, parallel-group studies of 331 and 331 pediatric patients with AOMT

  • OTOVEL delivered significantly shorter times to cessation of otorrhea vs ciprofloxacin or fluocinolone acetonide alone

Study design

chart depicting the study design of Otovel vs. the use of Ciprofloxacin only and Fluocinolone acetonide only

Study design: The efficacy and tolerability of OTOVEL were evaluated in two phase III multicenter, randomized, double-blind, active-controlled, parallel-group studies of pediatric patients (N=331 per study) of either sex aged 6 months to 12 years with AOMT in at least one ear, who presented with otorrhea for 3 weeks or less, and with moderate or severe purulent otorrhea at inclusion. Exclusion criteria included: tympanostomy tubes (TT) placement 3 days or less before study entry; TT containing antiseptic or antibacterial activity; T-type tubes; otitis externa; suspected viral, fungal, or mycobacterial ear infection; use of topical or systemic antimicrobial, antifungal, or steroid agents within the previous 7 days of study entry; concurrent use of anti-inflammatory agents. The primary endpoint was time to cessation of otorrhea (TCO), defined as the first day on which otorrhea was absent and remained absent until the end of the study.2

Study 1: Median time to cessation (days)1*†

chart of study 1: median time to cessation, Otovel 3.75 days and Ciprofloxacin 7.69 days

51.2% SHORTER

median time to cessation of otorrhea vs ciprofloxacin alone1

P<0.001, log-rank test stratified by age (patients younger than 3 years vs 3 years and older).

N.E. = not estimable because the number of censored patients was greater than the number of patients with cessation of otorrhea.

*Kaplan-Meier median estimate censored all subjects who did not have a cessation of otorrhea at the maximum time point of 22 days.

Study 1: Time to cessation of otorrhea3*†

otovel efficacy graph

78.6%

OTOVEL patients experiencing cessation of otorrhea by the end of therapy through the test of cure1

67.0%

ciprofloxacin alone1

48.2%

fluocinolone acetonide alone1

*Kaplan-Meier median estimate censored all subjects who did not have a cessation of otorrhea at the maximum time point of 22 days.

Study 2: Median time to cessation (days)1*†

chart of study 2: median time to cessation, Otovel 4.94 days, Ciprofloxacin 6.83 days

27.7% SHORTER

median time to cessation of otorrhea vs ciprofloxacin alone1

P=0.028, log-rank test stratified by age (patients younger than 3 years vs 3 years and older).

N.E. = not estimable because the number of censored patients was greater than the number of patients with cessation of otorrhea.

*Kaplan-Meier median estimate censored all subjects who did not have a cessation of otorrhea at the maximum time point of 22 days.

Study 2: Time to cessation of otorrhea3*†

Otovel efficacy graph study 2

78.4%

OTOVEL patients experiencing cessation of otorrhea by the end of therapy through the test of cure1

68.8%

ciprofloxacin alone1

43.5%

fluocinolone acetonide alone1

*Kaplan-Meier median estimate censored all subjects who did not have a cessation of otorrhea at the maximum time point of 22 days.

†Study design: The efficacy and tolerability of OTOVEL were evaluated in two phase III multicenter, randomized, double-blind, active-controlled, parallel-group studies of pediatric patients (N=331 per study) of either sex aged 6 months to 12 years with AOMT in at least one ear, who presented with otorrhea for 3 weeks or less, and with moderate or severe purulent otorrhea at inclusion. Exclusion criteria included: tympanostomy tubes (TT) placement 3 days or less before study entry; TT containing antiseptic or antibacterial activity; T-type tubes; otitis externa; suspected viral, fungal, or mycobacterial ear infection; use of topical or systemic antimicrobial, antifungal, or steroid agents within the previous 7 days of study entry; concurrent use of anti-inflammatory agents. The primary endpoint was time to cessation of otorrhea (TCO), defined as the first day on which otorrhea was absent and remained absent until the end of the study.2

▼ IMPORTANT SAFETY INFORMATION

Contraindications
OTOVEL is contraindicated in:

  • Patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin or other quinolones, or to any other components of OTOVEL.

  • Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections.

INDICATIONS

OTOVEL® (ciprofloxacin and fluocinolone acetonide) is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to S. aureus, S. pneumoniae, H. influenzae, M. catarrhalis, and P. aeruginosa.

IMPORTANT SAFETY INFORMATION

Contraindications
OTOVEL is contraindicated in:

  • Patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin or other quinolones, or to any other components of OTOVEL.

  • Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections.

Warnings and Precautions
Hypersensitivity Reactions - OTOVEL should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria and itching. Serious acute hypersensitivity reactions may require immediate emergency treatment.

Potential for Microbial Overgrowth with Prolonged Use - Prolonged use of OTOVEL may result in overgrowth of non-susceptible bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy.

Continued or Recurrent Otorrhea - If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within 6 months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

Adverse Reactions
The most common adverse reactions that occurred in 1 or more of the patients are otorrhea, excessive granulation tissue, ear infection, ear pruritus, tympanic membrane disorder, auricular swelling, and balance disorder.

For additional safety information, consult the Otovel full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

References: 1. OTOVEL [package insert]. Ridgeland, MS: WraSer Pharmaceuticals. 2. Spektor Z, Pumarola P, Ismail K, et al. Efficacy and safety of ciprofloxacin plus fluocinolone in otitis media with tympanostomy tubes in pediatric patients: a randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2017;143(4):341-349. 3. Data on file, WraSer Pharmaceuticals, Inc.