ADAPALENE
Generic: ADAPALENE
Basic Information
Manufacturer
Alembic Pharmaceuticals Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
a3b6f3c3-d615-4b00-a76f-134b75e30a50
Indications & Usage
1 INDICATIONS AND USAGE Adapalene gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Adapalene gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
( 1 )
Adapalene gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The most frequently reported (≥1%) adverse reactions were erythema, scaling, dryness, and/or burning/stinging.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc.
at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In the multi-center, controlled clinical trial, signs and symptoms of local cutaneous irritation were monitored in 258 acne subjects who used adapalene gel once daily for 12 weeks.
Of the subjects who experienced cutaneous irritation (erythema, scaling, dryness, and/or burning/stinging), the majority of cases were mild to moderate in severity, occurred early in treatment and decreased thereafter.
The incidence of local cutaneous irritation with adapalene gel from the controlled clinical trial is provided in the following table: Table 1: Physician assessed local cutaneous irritation with Adapalene Gel * Total number of subjects with local cutaneous data for at least one post-Baseline evaluation.
Incidence of Local Cutaneous Irritation with Adapalene Gel (N = 253*) Maximum Severity Scores Higher Than Mild Moderate Severe Erythema 66 (26.1%) 33 (13.0%) 1 (0.4%) Scaling 110 (43.5%) 47 (18.6%) 3 (1.2%) Dryness 113 (44.7%) 43 (17.0%) 2 (0.8%) Burning/Stinging 72 (28.5%) 36 (14.2%) 9 (3.6%) Table 2: Patient reported local cutaneous adverse reactions with Adapalene Gel *Selected adverse reactions defined by investigator as Possibly, Probably or Definitely Related Adapalene Gel Vehicle Gel N=258 N=134 Related* Adverse Reactions 57 (22.1%) 6 (4.5%) Dry Skin 36 (14%) 2 (1.5%) Skin Discomfort 15 (5.8%) 0 (0.0%) Desquamation 4 (1.6%) 0 (0.0%) The following adverse reactions occurred in less than 1% of subjects: acne flare, contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.
In a one-year, open-label safety trial of 551 subjects with acne who received adapalene gel, the pattern of adverse reactions was similar to the 12-week controlled study.
6.2 Post-Marketing Experience The following adverse reactions have been identified during post approval use of adapalene: Immune system disorders: angioedema, face edema, lip swelling Skin disorders: application site pain Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc.
at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In the multi-center, controlled clinical trial, signs and symptoms of local cutaneous irritation were monitored in 258 acne subjects who used adapalene gel once daily for 12 weeks.
Of the subjects who experienced cutaneous irritation (erythema, scaling, dryness, and/or burning/stinging), the majority of cases were mild to moderate in severity, occurred early in treatment and decreased thereafter.
The incidence of local cutaneous irritation with adapalene gel from the controlled clinical trial is provided in the following table: Table 1: Physician assessed local cutaneous irritation with Adapalene Gel * Total number of subjects with local cutaneous data for at least one post-Baseline evaluation.
Incidence of Local Cutaneous Irritation with Adapalene Gel (N = 253*) Maximum Severity Scores Higher Than Mild Moderate Severe Erythema 66 (26.1%) 33 (13.0%) 1 (0.4%) Scaling 110 (43.5%) 47 (18.6%) 3 (1.2%) Dryness 113 (44.7%) 43 (17.0%) 2 (0.8%) Burning/Stinging 72 (28.5%) 36 (14.2%) 9 (3.6%) Table 2: Patient reported local cutaneous adverse reactions with Adapalene Gel *Selected adverse reactions defined by investigator as Possibly, Probably or Definitely Related Adapalene Gel Vehicle Gel N=258 N=134 Related* Adverse Reactions 57 (22.1%) 6 (4.5%) Dry Skin 36 (14%) 2 (1.5%) Skin Discomfort 15 (5.8%) 0 (0.0%) Desquamation 4 (1.6%) 0 (0.0%) The following adverse reactions occurred in less than 1% of subjects: acne flare, contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.
In a one-year, open-label safety trial of 551 subjects with acne who received adapalene gel, the pattern of adverse reactions was similar to the 12-week controlled study.
6.2 Post-Marketing Experience The following adverse reactions have been identified during post approval use of adapalene: Immune system disorders: angioedema, face edema, lip swelling Skin disorders: application site pain Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.