FDA

Amzeeq

Approved 18 Oct 2019TopicalAerosol, foam

Indications

AMZEEQ is indicated for the topical treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older [ see Clinical Studies ( 14 ) ]. Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated [ see Warnings and Precautions ( 5.14 ) ].

AMZEEQ is a tetracycline-class drug indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. ( 1 ) Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated.

( 5.14 )

Contraindications

This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any other ingredients within AMZEEQ. This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any of the ingredients within AMZEEQ. ( 4 )

Warnings and precautions

The propellant in AMZEEQ is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. ( 5.1 ) The use of tetracycline-class of drugs orally during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth. ( 5.2 , 5.3 , 5.4 , 8.1 , 8.4 ) If Clostridioides difficile associated diarrhea occurs, discontinue AMZEEQ.

( 5.5 ) If liver injury is suspected, discontinue AMZEEQ. ( 5.6 ) If renal impairment exists, oral minocycline doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver toxicity. ( 5.7 ) Oral minocycline may cause central nervous system side effects including lightheadedness, dizziness, or vertigo. ( 5.8 ) Oral minocycline may cause intracranial hypertension in adults and adolescents.

Discontinue AMZEEQ if symptoms occur. ( 5.9 ) Oral minocycline has been associated with autoimmune syndromes; discontinue AMZEEQ immediately if symptoms occur. ( 5.10 ) Photosensitivity can occur with oral tetracycline. Patients should minimize or avoid exposure to natural or artificial sunlight. ( 5.11 ) Oral minocycline has been associated with anaphylaxis, serious skin reactions, erythema multiforme, and DRESS syndrome.

At a glance

Brand name: Amzeeq
Active substance: minocycline hydrochloride
Route: Topical
Dosage form: Aerosol, foam
Applicant: Journey
Status: Prescription
FDA approval: 18 Oct 2019
Application: NDA212379-001

Indications

( 5.14 )

Warnings and precautions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Available data with AMZEEQ use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Systemic absorption of AMZEEQ in humans is low following once daily topical administration of AMZEEQ for 21 days [see Clinical Pharmacology ( 12.3 )] . Because of low systemic exposure, it is not expected that maternal use of AMZEEQ will result in significant fetal exposure to the drug.

Tetracycline-class drugs may cause permanent discoloration of teeth and reversible inhibition of bone growth when administered orally during pregnancy [see Warnings and Precautions ( 5.2 , 5.3 , 5.4 ) and Use in Specific Populations ( 8.4 )] . Animal reproduction studies were not conducted with AMZEEQ. In animal reproduction studies, oral administration of minocycline administered to pregnant rats and rabbits during the period of organogenesis induced skeletal malformations in fetuses at systemic exposures of 750 and 500 times, respectively, the maximum recommended human dose (MRHD; based on AUC comparison) of AMZEEQ ( see Data ).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development of the developing fetus [ see Warnings and Precautions ( 5.2 ) ].

Minocycline induced skeletal malformations (bent limb bones) in fetuses when orally administered to pregnant rats and rabbits during the period of organogenesis at doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (750 and 500 times, respectively, the systemic exposure at the MRHD based on AUC comparison). Reduced mean fetal body weight was observed when minocycline was orally administered to pregnant rats during the period of organogenesis at a dose of 10 mg/kg/day (250 times the systemic exposure at the MRHD based on AUC comparison).

Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats during the period of organogenesis through lactation, at doses of 5, 10, or 50 mg/kg/day. In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (650 times the systemic exposure at the MRHD based on AUC comparison). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed.

Gross external anomalies observed in F1 pups (offspring of animals that received oral minocycline) included reduced body size, improperly rotated forelimbs, and reduced size of extremities. No effects were observed on the physical development, behavior, learning ability, or reproduction of F1 pups, and there was no effect on gross appearance of F2 pups (offspring of F1 animals).

Adverse reactions

The most commonly observed adverse reaction is headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Journey Medical Corporation at 1-855-531-1859 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction 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 3 randomized, double-blind, vehicle-controlled trials, subjects age 9 years and older applied AMZEEQ or vehicle once daily for 12 weeks. A total of 1,356 subjects were treated with AMZEEQ and 1,058 with vehicle.

The majority of subjects were White (74%) and female (60%). Approximately 34% were Hispanic/Latino and 49% were younger than 18 years of age. The most common adverse reaction reported by ≥1% of subjects treated with AMZEEQ and more frequently than in subjects treated with vehicle was headache, which was reported in 3% of subjects treated with AMZEEQ and 2% of subjects treated with vehicle. Local tolerability evaluations were conducted at each study visit in the clinical trial by assessment of erythema, dryness, hyperpigmentation, skin peeling and itching.

Table 1 presents the active assessment of the signs and symptoms of local facial tolerability at Week 12 in subjects treated with AMZEEQ. Local tolerability signs and symptoms occurred in similar frequency and severity as subjects treated with the vehicle component of AMZEEQ. Table 1: Facial Cutaneous Tolerability Assessment AMZEEQ, % (N=1,377) Symptom/Severity Mild Moderate Severe Erythema 14.2 1.5 0 Dryness 6.8 0.6 0 Hyperpigmentation Hyperpigmentation was most frequently assessed as characteristic of inflammatory and post-inflammatory changes associated with acne. 12.4 2.8

0.1 Skin Peeling 3.2 0.2 0 Itching 5.1 0.8

0.1 In a 40-week open-label extension safety study (for a total of up to 52 weeks of treatment), frequency and severity of local tolerability signs and symptoms at Week 52 were comparable to those reported at Week 12.

Amzeeq

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Amzeeq

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Flammability

5.2Teratogenic Effects

5.3Tooth Discoloration

5.4Inhibition of Bone Growth

5.6Hepatotoxicity

5.7Metabolic Effects

5.8Central Nervous System Effects

5.9Intracranial Hypertension

5.10Autoimmune Syndromes

5.11Photosensitivity

Interactions

7.1Anticoagulants

7.2Penicillin

7.3Drug/Laboratory Test Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

Composition

Official product information