Twyneo
Generic: BENZOYL PEROXIDE AND TRETINOIN
Basic Information
Manufacturer
Mayne Pharma Commercial LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
654ae869-5bc0-40b3-a423-dcc3270c05d8
Indications & Usage
1 INDICATIONS AND USAGE TWYNEO is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older.
TWYNEO is a combination tretinoin, a retinoid, and benzoyl peroxide indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older.
( 1 )
TWYNEO is a combination tretinoin, a retinoid, and benzoyl peroxide indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥ 1%) are pain, dryness, exfoliation erythema, dermatitis, pruritus and irritation (all at the application site).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma.
at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical trials experience The following adverse reactions are discussed in greater detail elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Skin Irritation [see Warnings and Precautions (5.2) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates are 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 two multicenter, randomized, double-blind, vehicle-controlled trials (Trial 1 and 2), 832 subjects 9 years of age and older with facial acne vulgaris applied TWYNEO (N=555) or vehicle (N=277) daily for 12 weeks.
The majority of subjects were White (73%) and female (59%).
Approximately 33% were Hispanic/Latino, and 46% were younger than 18 years of age.
Adverse reactions reported in ≥ 1.0% of subjects treated with TWYNEO (and for which the rate exceeded the rate for vehicle), as well as the corresponding rates reported in subjects treated with vehicle are presented in Table 1.
Table 1: Adverse Reactions Reported by ≥ 1% of Subjects with Facial Acne Vulgaris Treated with TWYNEO and More Frequently than Vehicle in Trials 1 and 2 TWYNEO Cream (N = 555) n (%) Vehicle Cream (N = 277) n (%) Application Site Pain Application site pain defined as application site stinging, burning or pain.
59 (10.6) 1 (0.4) Application Site Dryness 27 (4.9) 1 (0.4) Application Site Exfoliation 23 (4.1) 0 Application Site Erythema 22 (4.0) 0 Application Site Dermatitis 7 (1.3) 1 (0.4) Application Site Pruritus 7 (1.3) 0 Application Site Irritation 6 (1.1) 1 (0.4) Local tolerability evaluations were conducted at each study visit in the clinical trial by assessment of erythema, scaling, pigmentation, dryness, itching, burning, and stinging.
Table 2 presents the active assessment of the signs and symptoms of local facial tolerability at Week 12 in subjects treated with TWYNEO.
Table 2.
Facial Cutaneous Tolerability Assessment at Week 12 in Subjects with Acne Vulgaris Treated with TWYNEO TWYNEO (N=494 The denominators for calculating the percentages were 494 of 555 subjects treated with TWYNEO and 264 of 277 subjects treated with vehicle in these trials who had cutaneous signs and local tolerability results reported at Week 12.
) (%) Vehicle (N = 264 ) (%) Mild Moderate Severe Mild Moderate Severe Erythema 33.0 6.9 0.2 26.9 8.0 0 Pigmentation 27.3 6.3 0.4 26.5 4.5 0 Dryness 22.3 5.3 0.4 16.7 2.3 0 Scaling 16.4 2.6 0 12.9 0.8 0 Burning 5.9 2.2 0 3.4 0.8 0 Itching 11.1 1.8 0 8.7 2.7 0 Stinging 5.3 0.2 0 1.9 1.1 0 Local tolerability scores for erythema, scaling, dryness, itching, burning, and stinging rose during the first two weeks of treatment and decreased thereafter.
6.2 Postmarketing Experience The following adverse reactions have been identified during use of benzoyl peroxide.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: Anaphylaxis, angioedema and urticaria
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma.
at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical trials experience The following adverse reactions are discussed in greater detail elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Skin Irritation [see Warnings and Precautions (5.2) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates are 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 two multicenter, randomized, double-blind, vehicle-controlled trials (Trial 1 and 2), 832 subjects 9 years of age and older with facial acne vulgaris applied TWYNEO (N=555) or vehicle (N=277) daily for 12 weeks.
The majority of subjects were White (73%) and female (59%).
Approximately 33% were Hispanic/Latino, and 46% were younger than 18 years of age.
Adverse reactions reported in ≥ 1.0% of subjects treated with TWYNEO (and for which the rate exceeded the rate for vehicle), as well as the corresponding rates reported in subjects treated with vehicle are presented in Table 1.
Table 1: Adverse Reactions Reported by ≥ 1% of Subjects with Facial Acne Vulgaris Treated with TWYNEO and More Frequently than Vehicle in Trials 1 and 2 TWYNEO Cream (N = 555) n (%) Vehicle Cream (N = 277) n (%) Application Site Pain Application site pain defined as application site stinging, burning or pain.
59 (10.6) 1 (0.4) Application Site Dryness 27 (4.9) 1 (0.4) Application Site Exfoliation 23 (4.1) 0 Application Site Erythema 22 (4.0) 0 Application Site Dermatitis 7 (1.3) 1 (0.4) Application Site Pruritus 7 (1.3) 0 Application Site Irritation 6 (1.1) 1 (0.4) Local tolerability evaluations were conducted at each study visit in the clinical trial by assessment of erythema, scaling, pigmentation, dryness, itching, burning, and stinging.
Table 2 presents the active assessment of the signs and symptoms of local facial tolerability at Week 12 in subjects treated with TWYNEO.
Table 2.
Facial Cutaneous Tolerability Assessment at Week 12 in Subjects with Acne Vulgaris Treated with TWYNEO TWYNEO (N=494 The denominators for calculating the percentages were 494 of 555 subjects treated with TWYNEO and 264 of 277 subjects treated with vehicle in these trials who had cutaneous signs and local tolerability results reported at Week 12.
) (%) Vehicle (N = 264 ) (%) Mild Moderate Severe Mild Moderate Severe Erythema 33.0 6.9 0.2 26.9 8.0 0 Pigmentation 27.3 6.3 0.4 26.5 4.5 0 Dryness 22.3 5.3 0.4 16.7 2.3 0 Scaling 16.4 2.6 0 12.9 0.8 0 Burning 5.9 2.2 0 3.4 0.8 0 Itching 11.1 1.8 0 8.7 2.7 0 Stinging 5.3 0.2 0 1.9 1.1 0 Local tolerability scores for erythema, scaling, dryness, itching, burning, and stinging rose during the first two weeks of treatment and decreased thereafter.
6.2 Postmarketing Experience The following adverse reactions have been identified during use of benzoyl peroxide.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: Anaphylaxis, angioedema and urticaria