FDA approves Ycanth as first molluscum contagiosum treatment
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Key takeaways:
- The approval was based on results from two phase 3 randomized, double-blind, multicenter trials, CAMP-1 and CAMP-2.
- Ycanth will be available commercially in September 2023.
The FDA has approved Ycanth topical solution for the treatment of the viral skin infection molluscum contagiosum in patients aged as young as 2 years, Verrica Pharmaceuticals announced in a press release.
Ycanth topical solution is a proprietary drug-device combination product that contains cantharidin 0.7%, which is delivered via a single-use applicator. This approval makes Ycanth the first-ever approved treatment in the United States for the approximately 6 million patients that suffer annually from molluscum contagiosum, according to the press release.
“We are proud to bring patients and caregivers the first FDA-approved treatment for molluscum, which is one of the largest unmet needs in medical dermatology,” Ted White, president and CEO of Verrica Pharmaceuticals, said in the release. “Approval of Ycanth is a historic transformational moment in medical dermatology, as physicians, patients and caregivers have long sought a safe and effective FDA-approved treatment for molluscum.”
The approval was based on results from two phase 3 randomized, double-blind, multicenter trials, CAMP-1 and CAMP-2. These trials evaluated the safety and efficacy of Ycanth, also called VP-102, compared with placebo in patients aged as young as 2 years with molluscum contagiosum.
VP-102 met the primary endpoint of a proportion of patients achieving complete clearance of all treatable molluscum lesions vs. placebo in CAMP-1 (46% vs. 18%; P < .0001) and CAMP-2 (54% vs. 13%; P < .0001).
According to the press release, 97% of patients treated with Ycanth experienced local skin reactions during application. However, adverse events were mostly mild to moderate and no serious adverse events were reported, with 2.3% of the Ycanth group discontinuing treatment due to adverse events compared with 0.5% treated with vehicle.
The road to approval for Ycanth was not without its challenges as the FDA previously denied Verrica's new drug application in May 2022. Now over a year later, patients suffering from this condition have an approved treatment option.
Molluscum is a highly contagious skin infection that is spread mostly among children in households, schools and during extra-curricular activities such as swimming. The topical application of Ycanth allows for precise administration to stop the skin-to-skin contact that facilitates the spread of this disease, according to the press release.
“Our commercial team is vigorously preparing for commercial launch,” White said, “and we look forward to working with health care providers to give patients and caregivers access to Ycanth by September 2023.”
Perspective
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Lawrence F. Eichenfield, MD
Molluscum contagiosum is an incredibly common condition, especially in children, and it is exciting to have an approved therapeutic agent to help us manage it. Molluscum commonly co-infects family members and 30% of individuals may have symptoms that persist for 30 months or longer without treatment.
Historically, one of the challenges of molluscum care was not having specifically studied and approved therapies, which encouraged a “wait and see” attitude amongst many primary care physicians. Further, while cantharidin was widely used in compounded formulations, its efficacy, safety, variability of concentrations and methods of application have limited its use.
Addressing this unmet need, Ycanth brings a standardized, consistent concentration of cantharidin 0.7% in a single-use vial. Ycanth is designed to allow direct, controlled application on molluscum, which is supported by a strong set of clinical studies showing ease of use, efficacy and favorable safety and tolerability. Ycanth not only has the potential to change the treatment paradigm but may also minimize the annoyance as well as secondary inflammation and infection associated with molluscum. I expect that Ycanth will be warmly welcomed by the dermatologic and pediatric communities, as well as by patients and families.
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