FDA Approves AKLIEF (Trifarotene) Cream for the Topical Treatment of Acne Vulgaris in Patients 9 Years of Age and Older
On October 4, 2019, the U.S. Food and Drug Administration (FDA) approved AKLIEF (trifarotene) Cream for the topical treatment of acne vulgaris in patients 9 years of age and older. AKLIEF Cream for topical administration contains 0.005% (50 mcg/g) trifarotene. The approved recommended dosage of AKLIEF Cream is a thin layer applied to the affected areas of the face and/or trunk once a day, in the evening, on clean and dry skin. The use of a moisturizer is recommended as frequently as needed from the initiation of treatment. Avoid contact with the eyes, lips, paranasal creases, and mucous membranes. AKLIEF Cream is not for oral, ophthalmic, or intravaginal use. Additional information regarding dosage and administration and important warnings and precautions about skin irritation and minimizing ultraviolet light and environmental exposure can be found in the full prescribing information linked below.
Mechanism of Action (MOA) and Pharmacokinetics (PK)
- MOA: Trifarotene is an agonist of retinoic acid receptors (RAR), with particular activity at the gamma subtype of RAR.
- General PK: Steady state Cmax ranged from below the limit of quantification (less than 5 pg/mL) to 10 pg/mL and AUC0-24h ranged from 75 to 104 pg.h/mL in adults. Steady state conditions were achieved in patients following 2 weeks of topical administration with no expected drug accumulation with long-term use in adult or pediatric patients.
- Distribution: Plasma protein binding is approximately 99.9%.
- Elimination: The terminal half-life ranged from 2 to 9 hours.
- Metabolism: Trifarotene is primarily metabolized by CYP2C9, CYP3A4, CYP2C8, and to a lesser extent by CYP2B6 in vitro.
- Excretion: Trifarotene is primarily excreted by the feces
Drug Interactions
Topical application of AKLIEF Cream is not expected to affect the circulating concentrations of oral hormonal contraceptives containing ethinyl estradiol and levonorgestrel.
Use in Specific Populations
Steady state Cmax ranged from less than 5 pg/mL to 9 pg/mL and AUC0-24h ranged from 89 to 106 pg.h/mL in pediatric patients (10-17 years old).
Efficacy and Safety
Efficacy of AKLIEF was demonstrated in the treatment of moderate facial and truncal acne vulgaris in two randomized, multicenter, parallel group, double-blind, vehicle-controlled trials of identical design. The trials were conducted in subjects aged 9 years and older, who were treated for up to 12 weeks with either AKLIEF Cream or vehicle cream. Additional information regarding efficacy trials can be found in the full prescribing information linked below.
Most common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site irritation, application site pruritus, and sunburn.
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