FABIOR (Page 3 of 5)

14 CLINICAL STUDIES

In 2 multi-center, randomized, double-blind, vehicle-controlled trials, a total of 1,485 subjects with moderate-to-severe acne vulgaris were randomized 1:1 to FABIOR Foam or vehicle applied once daily for 12 weeks. Acne severity was evaluated using lesion counts and the 6-point Investigator’s Global Assessment (IGA) scale (see Table 2). At baseline, 80% of subjects were graded as “moderate” or Grade 3 and 20% were graded as “severe” or Grade 4 on the IGA scale. At baseline, subjects had an average of 79.8 total lesions of which the mean number of inflammatory lesions was 31.9 and the mean number of non-inflammatory lesions was 47.8. Subjects ranged in age from 12 to 45 years, with 860 (58%) subjects aged 12 to 17 years; 428 (29%) subjects aged 18 to 25 years; 143 (10%) subjects aged 26 to 35 years and 54 (4%) subjects aged 36 to 45 years. Subjects enrolled in the trials by race were white (77%), black (15%), Asian (4%), and other (4%). Hispanics comprised 18% of the population. An equal number of males (49%) and females (51%) were enrolled. Treatment success was defined as a score of “clear” (Grade 0) or “almost clear” (Grade 1) and at least 2-grade improvement from the baseline score to Week 12.

Table 2. Investigator’s Global Assessment Scale
Grade Description
0 Clear Clear skin with no inflammatory or non-inflammatory lesions.
1 Almost clear Rare non-inflammatory lesions with no more than rare papules.
2 Mild Greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions).
3 Moderate Greater than Grade 2, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion.
4 Severe Greater than Grade 3, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions.
5 Very severe Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.

Absolute and percent reductions in lesion counts and the IGA scale after 12 weeks of treatment in these 2 trials are shown in Table 3. Each trial needed to have a statistically significant reduction in 2 out of 3 lesion counts at Week 12.

Table 3. Reductions in Lesion Counts and Improvements in Investigator’s Global Assessment at Week 12
Trial 1 Trial 2
FABIOR Foam
N = 371
Vehicle Foam
N = 372
FABIOR Foam
N = 373
Vehicle Foam
N = 369
Inflammatory Lesions
Mean absolute reduction from Baseline 18.0 14.0 18.0 15.0
Mean percent reduction from Baseline 58% 45% 55% 45%
Non-inflammatory Lesions
Mean absolute reduction from Baseline 28.0 17.0 26.0 18.0
Mean percent reduction from Baseline 55% 33% 57% 41%
Total Lesions
Mean absolute reduction from Baseline 46.0 31.0 43.0 33.0
Mean percent reduction from Baseline 56% 39% 56% 43%
Investigator’s Global Assessment (IGA), n (%)
Minimum 2-grade improvement and IGA of 0 or 1 107 (29%) 60 (16%) 103 (28%) 49 (13%)

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied:

FABIOR Foam, 0.1% (1 mg/g) is a white to off-white foam, supplied as follows:

50-g aluminum can NDC 51862-295-50
100-g aluminum can NDC 51862-295-10

Storage and Handling:

  • Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP-controlled room temperature.
  • Store upright.
  • Protect from freezing.
  • Flammable. Avoid fire, flame, or smoking during and immediately following application. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C).
  • Shake can before use. Hold can at an upright angle and press firmly to dispense.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information).

Inform the patient of the following:

  • Fetal risk associated with FABIOR Foam for females of childbearing potential. Advise patients to use an effective method of contraception during treatment to avoid pregnancy. Advise the patient to stop medication if she becomes pregnant and call her doctor.
  • If undue irritation (redness, peeling, or discomfort) occurs, reduce frequency of application or temporarily interrupt treatment. Treatment may be resumed once irritation subsides.
  • Do not place FABIOR Foam in the freezer.
  • Avoid exposure of the treated areas to either natural or artificial sunlight, including tanning beds and sun lamps.
  • Avoid contact with the eyes. If FABIOR Foam gets in or near their eyes, to rinse thoroughly with water.
  • Wash their hands after applying FABIOR Foam.
  • Avoid fire, flame, or smoking during and immediately following application since FABIOR Foam is flammable.
  • Keep out of the reach of children.
  • Not for ophthalmic, oral, or intravaginal use.

FABIOR is a licensed trademark of Mayne Pharma LLC used under license to Mayne Pharma Inc.

©2016 Mayne Pharma All rights reserved.1240 Sugg Parkway Greenville NC 27834

Manufactured for:
Mayne Pharma
Greenville, NC 27834

140823

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