Efficacy

IN CLINICAL TRIALS—

YCANTH™ provided complete clearance within 12 weeks1

Photo is illustrative and not representative of all patients.

YCANTH provided complete clearance of baseline and new lesions within 12 weeks1

Complete clearance: pooled CAMP-1 and CAMP-2 data (ITT population)1,3*

CAMP-1 statistical significance at days 21, 42, 63, and 84.
CAMP-2 significance at days 42, 63, and 84.2

*The intent to treat (ITT) population included patients randomized to receive either YCANTH or vehicle.1

CAMP-1/CAMP-2=Cantharidin Application in Molluscum Patients-1 and -2; ITT=intent to treat.

  • The primary efficacy endpoint was the percentage of patients with complete clearance of baseline and new lesions by day 84 with YCANTH vs vehicle2:

CAMP-13

46% vs 18%
(P<0.0001)

CAMP-23

54% vs 13%
(P<0.0001)

  • 78% of YCANTH-treated patients achieved ≥75% clearance compared with 35% of vehicle-treated patients by the end of the CAMP-1 and CAMP-2 trials5

Adverse reactions were primarily mild to moderate local skin reactions at the application site and included vesiculation, pain, pruritus, discoloration, and erythema.4 See additional Important Safety Information throughout.

YCANTH phase 3 clinical trial results3

Visit 1

Day 1

24 hours post-
treatment 1

Visit 2

Day 21

Visit 3

Day 42

Visit 4

Day 63

Day 84
EOS

These images represent the lesions of a YCANTH-treated patient in a phase 3 study—individual results may vary.

EOS=end of study.

The CAMP-1 and CAMP-2 phase 3 clinical trials enrolled 528 patients (CAMP-1: N=266; CAMP-2: N=262) with molluscum aged 2 years and older. Patients with active or a history of atopic dermatitis were included in the studies. Study drug (YCANTH or vehicle) was administered topically to all baseline and new lesions approximately every 21 days until complete lesion clearance or up to 4 applications.2,4 Assessments of expected application-site reactions, including incidence/size of blisters, erythema, pain, pruritus, and edema, were conducted at each visit through patient/caregiver report, as well as at 24 hours, 7 days, and 14 days after each treatment.2

SeeHide additional Study Design information

YCANTH was studied in patients aged 2 years and older4

Patient characteristics

Pooled baseline characteristics of patients in CAMP-1 and CAMP-2 trials (ITT population)1,6

n=309.3
SD=standard deviation.

Mean (SD) age of patients
treated with YCANTH2


CAMP-1:  7.5 (5.3) years

CAMP-2:  7.4 (8.0) years

Mean (SD) lesion count in
patients in the YCANTH group2


CAMP-1:  21.9 (23.6)

CAMP-2:  18.7 (22.9)

Reduction in lesion count in YCANTH- and vehicle-treated patients1

YCANTH phase 3 clinical trial results3

Visit 1

Day 1

24 hours post-
treatment 1

Visit 2

Day 21

Visit 3

Day 42

Visit 4

Day 63

Day 84
EOS

These images represent the lesions of a YCANTH-treated patient in a phase 3 study—individual results may vary.

Pooled CAMP-1 and CAMP-2 mean percentage change in lesion count from baseline to day 84 (ITT population)1

The data represented in this graph are the result of an exploratory endpoint.

  • By day 84, patients treated with YCANTH had a mean percentage reduction in lesion count from baseline of 76% compared with a 0.3% reduction in patients treated with vehicle (P<0.0001)1

CAMP-12


YCANTH:  69% reduction

Vehicle:  20% increase

CAMP-22


YCANTH:  83% reduction

Vehicle:  19% increase

YCANTH is safe to use on most areas of the body

§Avoid application near the eyes and mucosal tissues, and to adjacent healthy skin.4

Percentage of patients with complete clearance by areas of the body (ITT population)1,3,6

The data represented in this graph are the result of an exploratory endpoint.

  • YCANTH-treated patients had an average of 2.4 areas of the body affected at baseline6
  • Significantly more YCANTH-treated patients experienced complete clearance of baseline and new lesions in all body regions by day 84 than vehicle-treated patients3,6

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: None.

WARNINGS AND PRECAUTIONS:

  • YCANTH is for topical use only. YCANTH is not for oral, mucosal, or ophthalmic use. Life threatening or fatal toxicities can occur if YCANTH is administered orally. Avoid contact with the treatment area, including oral contact, after treatment. Ocular toxicity can occur if YCANTH comes in contact with eyes. If YCANTH gets in eyes, flush eyes with water for at least 15 minutes.

INDICATION

YCANTH (cantharidin) topical solution, 0.7% is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: None.

WARNINGS AND PRECAUTIONS:

  • YCANTH is for topical use only. YCANTH is not for oral, mucosal, or ophthalmic use. Life threatening or fatal toxicities can occur if YCANTH is administered orally. Avoid contact with the treatment area, including oral contact, after treatment. Ocular toxicity can occur if YCANTH comes in contact with eyes. If YCANTH gets in eyes, flush eyes with water for at least 15 minutes.
  • Local Skin Reactions: Reactions at the application site may occur, including vesiculation, pruritus, pain, discoloration, and erythema. Avoid application near eyes and mucosal tissue, and to healthy skin. If YCANTH contacts any unintended surface, or healthy skin, immediately remove. If severe local skin reactions occur, remove prior to the recommended 24 hours after treatment.
  • YCANTH is flammable, even after drying. Avoid fire, flame or smoking near lesion(s) during treatment and after application until removed.

ADVERSE REACTIONS:

The most common (incidence ≥1%) reactions are the following local skin reactions at the application site: vesiculation, pain, pruritus, scabbing, erythema, discoloration, application site dryness, edema, and erosion. Local skin reactions at the application site were observed in 97% of subjects treated with YCANTH during clinical trials. These local skin reactions are expected and related to the anticipated blistering response of the skin to cantharidin.

DRUG INTERACTIONS:

No studies evaluating the drug interaction potential of cantharidin have been conducted.

USE IN SPECIFIC POPULATIONS:

Pregnancy: There are no available data with use of YCANTH in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Given that systemic exposure to cantharidin following topical administration is low, maternal use is not expected to result in fetal exposure to the drug.

Lactation: Avoid application of YCANTH topical solution to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child.

OVERDOSAGE:

Oral ingestion of cantharidin has resulted in renal failure, blistering and severe damage to the gastrointestinal tract, coagulopathy, seizures, and flaccid paralysis.

Please see full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Verrica Pharmaceuticals Inc. at 1-877-VERRICA (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.