Ycanth (cantharidin) / Verrica, Japan Tobacco - LARVOL DELTA

Verrica Pharmaceuticals Reports Strong Demand-Led Growth in YCANTH Dispensed Applicator Units in First Quarter 2025 (GlobeNewswire) - "Verrica Pharmaceuticals Inc...announced that Company experienced strong demand-led growth for YCANTH in the first quarter of 2025, with the number of dispensed applicator units increasing to 10,102 in the first quarter. This first quarter growth represents a sequential increase of 16.7% over the fourth quarter of 2024 (8,654 dispensed applicator units)."

Commercial • Dermatology

Safety and Efficacy of TO-208 in Japanese Children and Adults with Molluscum Contagiosum: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial (AAD 2025) - "The results demonstrate TO-208 is an effective and well-tolerated MC treatment option in Japanese patients aged 2 and older. *Approved in US with coloring agent, as VP-102."

Clinical • P3 data • Dermatology • Infectious Disease

Verrica Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results (GlobeNewswire) - "...'We also anticipate advancing VP-102 (YCANTH) into a Phase 3 clinical trial for the treatment of common warts as early as mid-2025'."

New P3 trial • Dermatology

Innovation in Warts and Molluscum: An Updated Comprehensive Review. (PubMed, Dermatol Clin) - "New treatment choices include VP-102 (Ycanth) for molluscum contagiosum, potentially intralesional Vitamin D3 for warts, and topical cidofovir for both. Traditional therapies like cryotherapy and keratolytic medicines remain the principal options. The study emphasizes the need for personalized treatment strategies and additional research to improve therapy efficacy and safety."

Journal • Review • Dermatology

Verrica Pharmaceuticals Reports Second Quarter 2024 Financial Results (GlobeNewswire) - "Reports YCANTH revenue, net of $4.9M for second quarter of 2024 along with the expansion of YCANTH’s distribution footprint to include Cencora, Inc. as a specialty distributor...'We are already beginning to see the effects of the permanent J-Code on increasing demand for YCANTH, as product coverage and reimbursement decisions for our Medicaid patient population become increasingly streamlined....Based on these two positive developments, coupled with our growing insurance coverage and distribution capabilities, we expect YCANTH prescription growth to continue quarter over quarter in the second half of 2024'."

Reimbursement • Sales • Dermatology

Cantharidin topical solution (Ycanth) for molluscum contagiosum. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dermatology

Verrica Pharmaceuticals Announces Receipt of Minutes from Type C Meeting with FDA Regarding Clinical Development of YCANTH for the Treatment of Common Warts (GlobeNewswire) - "Verrica Pharmaceuticals Inc....today announced that it received the minutes from the Company’s recent Type C meeting with the U.S. Food and Drug Administration (FDA), which was held on November 6, 2023, to discuss the Phase 3 clinical development plan for YCANTH for the treatment of common warts...the Company believes that the Type C meeting satisfied its objective to gain the FDA’s advice and agreement on the overall design of a pivotal Phase 3 study of YCANTH that would support an efficacy supplement for the proposed indication of common warts."

FDA event • Dermatology

Verrica Pharmaceuticals Announces Specialty Pharmacy Partnership Agreement with Walgreens to Distribute YCANTH (GlobeNewswire) - "Verrica Pharmaceuticals Inc...announced that it is growing its distribution network by entering into an agreement with Walgreen Co. ('Walgreens') to distribute YCANTH™ through its specialty pharmacy. Walgreens joins Verrica’s existing specialty pharmacy, Nufactor, who continues to be instrumental in helping the Company build awareness of YCANTH therapy among high volume dermatology and pediatric medical practices."

Commercial • Dermatology

Cantharidin Topical Solution 0.7%: First Approval. (PubMed, Paediatr Drugs) - "In July 2023, YCANTH™ (cantharidin 0.7% topical solution) was approved for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older in the USA. This article summarizes the milestones in the development of cantharidin 0.7% topical solution leading to this first approval for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older."

Journal • Review • Dermatology • Pediatrics

YCANTH (Cantharidin) Topical Solution. (PubMed, Skinmed) - "Common adverse events were mild to moderate, such as lesions at the site of application, pruritus, and pain. The recommended regimen of cantharidin topical solution is its application once every 21 days until complete clearance of lesions is observed, or up to four treatments."

Clinical • Journal • Dermatology • Inflammation • Pain • Pruritus

Verrica Pharmaceuticals Announces FDA Approval of YCANTH (cantharidin) topical solution as the First FDA approved Treatment of Pediatric and Adult Patients with Molluscum Contagiosum (GlobeNewswire) - "Verrica Pharmaceuticals Inc...announced U.S. Food and Drug Administration (FDA) approval of YCANTH™ (cantharidin) topical solution for the treatment of molluscum contagiosum (molluscum) in adult and pediatric patients 2 years of age and older....Verrica plans to make YCANTH™ available by September 2023. The approval is based on positive results from two identical Phase 3 randomized, double-blind, multicenter clinical trials (CAMP-1 and CAMP-2)..."

Launch • NDA • Dermatology

Molluscum Contagiosum Virus Evasion of Immune Surveillance: A Review. (PubMed, J Drugs Dermatol) - "MCV is distinctive in evading immune surveillance by inhibiting or dampening several immune pathways via the production of viral proteins. The result is decreasing local inflammatory response which contributes to the prolonged survival of MCV in the epidermis. Persistent MC can be a nuisance for some patients and treatment may be desired. Currently, no treatment has been approved by the US Food and Drug Administration (FDA). Two approaches in the pipeline may affect the immune avoidance mechanisms; nevertheless, their exact mechanisms between the potential therapeutics and viral proteins remain enigmatic. J Drugs Dermatol. 2023;22(2):182-189. doi:10.36849/JDD.7230."

Journal • Review • Dermatology • Immunology • Infectious Disease • Inflammation • Pediatrics

Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum (GlobeNewswire) - "Verrica Pharmaceuticals...today announced that it has resubmitted the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum) to the U.S. Food and Drug Administration (FDA)...'We look forward to working with the FDA through the review process, and if approved, bringing VP-102 to patients as the first FDA-approved treatment option for molluscum.'"

NDA • Dermatology

"$VRCA Verrica Pharmaceuticals Announces the Successful Technology Transfer of Bulk Solution Manufacturing of VP-102 to Piramal Pharma Solutions https://t.co/RckBTXKnEh" (@stock_titan)

New Developing Treatments for Molluscum Contagiosum. (PubMed, Dermatol Ther (Heidelb)) - "Two experimental topical drugs, a new standardized preparation of topical cantharidin, called VP-102, and a topical nitric oxide (NO)-releasing product containing berdazimer, called SB206, represent promising products that have been designed to overcome the limitations of current treatments. They have recently shown good results in terms of safety and efficacy in large cohorts of patients in phase III studies and have the potential to be the first FDA-approved therapies for the treatment of MC."

Journal • Review • Dermatology • Pain

Safety and Efficacy of VP-102 (Cantharidin, 0.7% w/v) in Molluscum Contagiosum by Body Region: Post hoc Pooled Analyses from Two Phase III Randomized Trials. (PubMed, J Clin Aesthet Dermatol) - P3 | "However, these analyses were post hoc, and individual lesions were not tracked for efficacy. VP-102 treatment shows consistent safety and efficacy across molluscum body regions."

Clinical • Journal • P3 data • Retrospective data • Dermatology • Infectious Disease • Pediatrics

"Keeping Track: US FDA Clears Vtama, But Not Bimekizumab Or Ycanth; Tibsovo Takes RTOR To Frontline AML Setting https://t.co/fCsHDK05fZ #PinkSheet" (@PharmaPinkSheet)

Acute Myelogenous Leukemia

Efficacy of topical treatments for molluscum contagiosum in randomized controlled trials. (PubMed, Clin Dermatol) - "Treatment modalities included podophyllotoxin, imiquimod, sodium nitrite, myrtle leaf extract, phenol, Salatac Gel (salicylic acid with lactic acid), potassium hydroxide, cantharidin, SB206, and VP-102. Overall, studies were of sufficient quality and had low risk of bias, but they had small sample sizes and lacked adequate explanation of statistical analysis. Current first-line treatment entails mechanical methods such as cryotherapy and curettage, which may be frightening to children with MC, so the development and assessment of topical treatments allows for alternative efficacious techniques."

Clinical • Journal • Review • Dermatology • Infectious Disease

Phase II, Double-Blind, Vehicle-Controlled Study to Determine the Cantharidin Dose Regimen, Efficacy, Safety, and Tolerability of VP-102 in Subjects with External Genital Warts. (PubMed, Am J Clin Dermatol) - P2 | "The adverse event profile and efficacy of VP-102 under occlusion demonstrated in this study support the conclusion that a 6-h or up to 24-h exposure regimen represents an acceptable risk:benefit profile and justifies the conduct of a larger vehicle-controlled phase III study in external genital warts."

Clinical • Journal • P2 data • Dermatology • Oncology • Pain

COVE-1: A Phase 2, Open-Label Study to Evaluate Efficacy and Safety and the Optimal Regimen of VP-102, a Proprietary Drug-Device Product Containing Topical Cantharidin (0.7% w/v) Under Occlusion for the Treatment of Common Warts. (PubMed, Dermatol Ther (Heidelb)) - P2 | "VP-102 showed efficacy in complete clearance of common warts from baseline to day 84, as well as at follow-up visits. Due to the higher percentage of patients exhibiting complete clearance in Cohort 2, the treatment regimen of Cohort 2 will be pursued in future studies. TEAEs were expected due to the pharmacodynamic action of cantharidin, a vesicant. Clinical Trials ID: NCT03487549."

Clinical • Journal • P2 data • Dermatology • Pain • Pruritus

[VIRTUAL] Safety and Efficacy of VP-102 in Molluscum Contagiosum by Age: Pooled Results of Two Phase 3 Multicenter, Randomized, Vehicle-Controlled Trials (AAD-VMX 2021) - "Treatment of molluscum with VP-102 showed higher efficacy across all ages at D84. Earlier clearance, along with a higher incidence of blistering was noted in children under age 12. The VP-102 group showed similar incidence of TEAEs across all ages."

Clinical • P3 data • Dermatology • Infectious Disease • Pruritus

Warts and All: Remedies Abound but High Quality Data Lacking (MedPageToday) - '"There's the regular cantharidin, and then there's the cantharidin with two other ingredients, salicylic acid and podophyllum,' he said. 'So I offer that, and tell them that between visits you can use Dr. Scholl's salicylic acid patch, or a generic version. Another one of my favorite compounds that's a little stronger is 5-fluorouracil with salicylic acid.' Tyring cautioned that even the stronger topical agents may be of limited efficacy against 'the really challenging areas of thick verruca vulgaris or the majority of plantar warts'...Topical cidofovir often works 'when everything else fails,' Tyring said. Compounded in a 3% cream for verrucae vulgaris and 5% for a plantar wart, applied daily for 2 to 4 weeks, will generally yield 'a dramatic response. It works best if you debulk the wart first; the patient can pare it down between applications at home, as long as they don't elicit pain or bleeding.' But this treatment may be limited by high out-of-pocket costs.'"

CARE: A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts (clinicaltrials.gov) - P2; N=105; Completed; Sponsor: Verrica Pharmaceuticals Inc.; Recruiting ➔ Completed; Trial completion date: Oct 2020 ➔ Jul 2020

Clinical • Trial completion • Trial completion date • Dermatology • Dermatopathology • Infectious Disease • Oncology

Safety and Efficacy of VP-102, a Proprietary, Drug-Device Combination Product Containing Cantharidin, 0.7% (w/v), in Children and Adults With Molluscum Contagiosum: Two Phase 3 Randomized Clinical Trials. (PubMed, JAMA Dermatol) - P3 | "These findings show that VP-102 is potentially an effective and safe treatment for MC, a common skin condition with no US Food and Drug Administration-approved treatments. ClinicalTrials.gov Identifiers: NCT03377790 and NCT03377803."

Clinical • Journal • P3 data • Dermatology • Pain • Pruritus

"$VRCA Receives CRL For VP-102 for the Treatment of Molluscum Contagiosum. FDA Requests Additional CMC and Human Factors Information" (@BioStocks)

Dermatology • Dermatopathology