ZILXI
Generic: MINOCYCLINE
Basic Information
Manufacturer
Journey Medical Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
cbffa96e-2446-43cf-ba5e-38c645302afd
Indications & Usage
1 INDICATIONS AND USAGE ZILXI is indicated for the treatment of inflammatory lesions of rosacea in adults [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, ZILXI should be used only as indicated [see Warnings and Precautions ( 5.14 )] .
ZILXI is a tetracycline-class drug indicated for the treatment of inflammatory lesions of rosacea in adults.
( 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, ZILXI should be used only as indicated ( 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, ZILXI should be used only as indicated [see Warnings and Precautions ( 5.14 )] .
ZILXI is a tetracycline-class drug indicated for the treatment of inflammatory lesions of rosacea in adults.
( 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, ZILXI should be used only as indicated ( 1 ).
Adverse Reactions
6 ADVERSE REACTIONS The most commonly observed adverse reaction (incidence ≥1%) is diarrhea.
( 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 .
6.1 Clinical 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 three (two Phase 3 and one Phase 2) multicenter, randomized, double-blind, vehicle-controlled trials, adult subjects applied ZILXI or vehicle once daily for 12 weeks.
A total of 1,087 subjects were treated with ZILXI and 591 with vehicle.
The majority of subjects were White (97%) and female (70%).
Approximately 67% were non-Hispanic/Latino.
The mean age was 50.0 years and ages ranged from 18 to 86 years.
The most common adverse reaction reported by ≥1% of subjects treated with ZILXI and more frequently than in subjects treated with vehicle was diarrhea (1% vs.
0%), respectively.
During the two Phase 3 trials, local tolerability evaluations were conducted at each study visit by assessment of erythema, telangiectasia, burning/stinging, flushing/blushing, dryness, itching, peeling and hyperpigmentation.
Table 1 presents local tolerance assessments by incidence rate (%) and severity grade.
Subjects treated with ZILXI had improved local tolerability signs and symptoms at Week 12 when compared with corresponding baseline values.
These occurred at a similar frequency and severity as subjects treated with the vehicle component of ZILXI.
Table 1: Facial Cutaneous Tolerability Assessment *Hyperpigmentation was most frequently assessed as characteristic of inflammatory and post-inflammatory changes associated with inflammatory lesions of rosacea.
** Of 1,008 subjects, 897 had local tolerability assessments at Week 12.
ZILXI, (%) (N=1,008**) Symptom/Severity Mild Moderate Severe Erythema 36.2 18.3 0.7 Telangiectasia 61.0 18.8 0 Burning/Stinging 13.3 2.8 0 Flushing/Blushing 39.0 9.6 0.9 Dryness 23.9 4.0 0.1 Itching 20.0 3.3 0 Skin Peeling 16.1 1.9 0.1 Hyperpigmentation* 22.5 2.8 0 In a 40-week open-label extension safety study of ZILXI (for a total of up to 52 weeks of treatment) [ NCT03276936 ], frequency and severity of local tolerability signs and symptoms at Week 52 were comparable to those reported at Week 12.
( 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 .
6.1 Clinical 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 three (two Phase 3 and one Phase 2) multicenter, randomized, double-blind, vehicle-controlled trials, adult subjects applied ZILXI or vehicle once daily for 12 weeks.
A total of 1,087 subjects were treated with ZILXI and 591 with vehicle.
The majority of subjects were White (97%) and female (70%).
Approximately 67% were non-Hispanic/Latino.
The mean age was 50.0 years and ages ranged from 18 to 86 years.
The most common adverse reaction reported by ≥1% of subjects treated with ZILXI and more frequently than in subjects treated with vehicle was diarrhea (1% vs.
0%), respectively.
During the two Phase 3 trials, local tolerability evaluations were conducted at each study visit by assessment of erythema, telangiectasia, burning/stinging, flushing/blushing, dryness, itching, peeling and hyperpigmentation.
Table 1 presents local tolerance assessments by incidence rate (%) and severity grade.
Subjects treated with ZILXI had improved local tolerability signs and symptoms at Week 12 when compared with corresponding baseline values.
These occurred at a similar frequency and severity as subjects treated with the vehicle component of ZILXI.
Table 1: Facial Cutaneous Tolerability Assessment *Hyperpigmentation was most frequently assessed as characteristic of inflammatory and post-inflammatory changes associated with inflammatory lesions of rosacea.
** Of 1,008 subjects, 897 had local tolerability assessments at Week 12.
ZILXI, (%) (N=1,008**) Symptom/Severity Mild Moderate Severe Erythema 36.2 18.3 0.7 Telangiectasia 61.0 18.8 0 Burning/Stinging 13.3 2.8 0 Flushing/Blushing 39.0 9.6 0.9 Dryness 23.9 4.0 0.1 Itching 20.0 3.3 0 Skin Peeling 16.1 1.9 0.1 Hyperpigmentation* 22.5 2.8 0 In a 40-week open-label extension safety study of ZILXI (for a total of up to 52 weeks of treatment) [ NCT03276936 ], frequency and severity of local tolerability signs and symptoms at Week 52 were comparable to those reported at Week 12.