han mild in Trial 1; and absence of blistering, exudates/pus, crusting, and itching/pain, and mild or improved erythema/inflammation in Trial 2. Table 2 below presents the results for clinical response at the end of therapy.
Table 2 Clinical Response at End of Therapy in Trial 1 and Trial 2 in All Randomized Subjects
Trial 1
Trial 2
XEPI
Placebo
XEPI
Placebo
(N = 155)
n (%)
(N = 156)
n (%)
(N = 206)
n (%)
(N = 206)
n (%)
a The success rates for ozenoxacin were significantly different than placebo in Study 1 and Study 2 (p = 0.002 and p = 0.001).
Clinical success 54 (34.8) 30 (19.2) 112 (54.4) 78 (37.9)
Clinical failure 98 (63.2) 120 (76.9) 91 (44.2) 121 (58.7)
Unable to determine 3 (1.9) 6 (3.8) 3 (1.5) 7 (3.4)
The most commonly identified bacteria were S. aureus and S. pyogenes. Table 3 below presents the results for clinical success at end of therapy in subjects with S.aureus or S.pyogenes at baseline.
Table 3 Clinical Success at End of Therapy in Trial 1 and Trial 2 in Subjects with S. aureus or S. pyogenes
Trial 1
Trial 2
XEPI
Placebo
XEPI
Placebo
Clinical success
n/N (%)
n/N (%)
n/N (%)
n/N (%)
S. aureus 35/93 (37.6) 16/98 (16.3) 66/115 (57.4) 36/108 (33.3)
S. pyogenes 29/73 (39.7) 7/67 (10.4) 15/19 (78.9) 8/20 (40.0)
16 HOW SUPPLIED/STORAGE AND HANDLING
XEPI cream, 1% is a pale yellow cream supplied in 10-, 30-, and 45-gram tubes. Each gram of cream contains 10 mg of ozenoxacin.
NDC 43538-320-10 (10-gram tube)
NDC 43538-320-30 (30-gram tube)
NDC 43538-320-45 (45-gram tube)
Store at 20ºC - 25ºC (68ºF - 77ºF); excursions permitted to 15ºC to 30ºC (59ºF - 86ºF) [See USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise patients (and/or their caregivers or guardians) using XEPI of the following information and instructions:
Use XEPI as directed by the healthcare practitioner. As with any topical medication, patients and caregivers should wash their hands after application if the hands are not the area for treatment.
XEPI is for external use only.Do not swallow XEPI or use it in the eyes, on the mouth or lips, inside the nose, or inside the female genital area.
The treated area may be covered by a sterile bandage or gauze dressing.
Use the medication for the entire time recommended by the healthcare practitioner, even though symptoms may have improved.
Notify the healthcare practitioner if there is no improvement in symptoms within 3 days after starting use of XEPI.
SPL UNCLASSIFIED SECTION
XEPI is a registered trademark of Medimetriks Pharmaceuticals Inc.
Manufactured for :
Medimetriks Pharmaceuticals, Inc., Fairfield, NJ 07004 USA
Manufactured by:
Teligent Pharma, Inc., Buena, NJ 08310 USA
© 2017, Medimetriks Pharmaceuticals. All rights reserved.
IP045
PRINCIPAL DISPLAY PANEL - 45 g Tube Box
Xepi™
(ozenoxacin) Cream, 1%
NDC 43538-320-45
For Topical Use Only
Not for Ophthalmic, Oral, Intranasal,
or Intravaginal Use
45g
Rx Only
MEDIMETRIKS
PHARMACEUTICALS, INC.
PRINCIPAL DISPLAY PANEL - 45 g Tube Box
INGREDIENTS AND APPEARANCE
