YCANTH
Generic: CANTHARIDIN
Basic Information
Manufacturer
Verrica Pharmaceuticals Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
7c9bdeaa-9822-4c69-a719-ea4a8643f59c
Indications & Usage
1 INDICATIONS AND USAGE YCANTH is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older.
YCANTH is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older.
( 1 )
YCANTH is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Local Skin Reactions [see Warnings and Precautions (5.2) ] Most common (incidence ≥1%) adverse reactions are the following local skin reactions at the application site: vesiculation, pain, pruritus, scabbing, erythema, discoloration, application site dryness, edema, and erosion.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Verrica Pharmaceuticals Inc.
at 1-877-837-7422 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Local skin reactions are expected and should be reported if they are severe.
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.
YCANTH was studied in two randomized, double-blind, placebo-controlled phase 3 trials, Trial 1 (NCT03377790) and Trial 2 (NCT03377803) (n = 266, and n = 262, respectively) in subjects with molluscum contagiosum.
Most patients received a single 24-hour dermal administration of YCANTH or vehicle for each lesion every 3 weeks for up to 4 treatments.
YCANTH Solution or vehicle were removed prior to the 24-hour timepoint in 109/311 (35%) subjects treated with YCANTH Solution and 46/216 (21%) subjects treated with vehicle due to treatment-emergent adverse events.
Table 1 presents the percentage of subjects with selected adverse reactions (incidence ≥ 1%) by the most severe grade reported during Trial 1 and Trial 2.
Adverse reactions were primarily local skin reactions at the application site.
Local skin reactions at the application site were observed in 97% of subjects treated with YCANTH during both trials.
Table 1.
Percentage of Subjects with Selected Adverse Reactions (Incidence ≥1%) by Severity in Trial 1 and Trial 2 (Safety Population) YCANTH N=311 Vehicle N=216 Preferred Term Name Mild Moderate Severe Mild Moderate Severe Application site vesicles 60% 32% 4% 27% 2% 0% Application site pain and pain 41% 20% 2% 16% 1% 0% Application site pruritus and pruritus 47% 8% 1% 30% 7% 0% Application site scab and scab 39% 9% 0% 20% 1% 0% Application site erythema and erythema 24% 21% <1% 20% 7% 0% Application site discoloration 28% 4% <1% 12% 1% 0% Application site dryness 19% 2% 0% 14% 1% 0% Application site edema 7% 3% 0% 3% 1% 0% Application site erosion 6% 1% 0% 1% 0% 0% Contact dermatitis 0% 1% 0% 0% 0% 0% There were no serious adverse reactions reported in the two controlled trials.
The discontinuation rate due to an adverse reaction was 2.3% among subjects treated with YCANTH and 0.5% among subjects treated with vehicle.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Verrica Pharmaceuticals Inc.
at 1-877-837-7422 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Local skin reactions are expected and should be reported if they are severe.
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.
YCANTH was studied in two randomized, double-blind, placebo-controlled phase 3 trials, Trial 1 (NCT03377790) and Trial 2 (NCT03377803) (n = 266, and n = 262, respectively) in subjects with molluscum contagiosum.
Most patients received a single 24-hour dermal administration of YCANTH or vehicle for each lesion every 3 weeks for up to 4 treatments.
YCANTH Solution or vehicle were removed prior to the 24-hour timepoint in 109/311 (35%) subjects treated with YCANTH Solution and 46/216 (21%) subjects treated with vehicle due to treatment-emergent adverse events.
Table 1 presents the percentage of subjects with selected adverse reactions (incidence ≥ 1%) by the most severe grade reported during Trial 1 and Trial 2.
Adverse reactions were primarily local skin reactions at the application site.
Local skin reactions at the application site were observed in 97% of subjects treated with YCANTH during both trials.
Table 1.
Percentage of Subjects with Selected Adverse Reactions (Incidence ≥1%) by Severity in Trial 1 and Trial 2 (Safety Population) YCANTH N=311 Vehicle N=216 Preferred Term Name Mild Moderate Severe Mild Moderate Severe Application site vesicles 60% 32% 4% 27% 2% 0% Application site pain and pain 41% 20% 2% 16% 1% 0% Application site pruritus and pruritus 47% 8% 1% 30% 7% 0% Application site scab and scab 39% 9% 0% 20% 1% 0% Application site erythema and erythema 24% 21% <1% 20% 7% 0% Application site discoloration 28% 4% <1% 12% 1% 0% Application site dryness 19% 2% 0% 14% 1% 0% Application site edema 7% 3% 0% 3% 1% 0% Application site erosion 6% 1% 0% 1% 0% 0% Contact dermatitis 0% 1% 0% 0% 0% 0% There were no serious adverse reactions reported in the two controlled trials.
The discontinuation rate due to an adverse reaction was 2.3% among subjects treated with YCANTH and 0.5% among subjects treated with vehicle.