FDA Accepts New VP-102 Application for Molluscum Contagiosum

The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Verrica Pharmaceutical’s drug candidate VP-102 for the treatment of molluscum contagiosum, according to the dermatology therapeutics company.¹

VP-102 will be decided upon as potentially the first treatment indicated for the viral-borne skin condition by its PDUFA goal date of July 23, 2023.

Verrica’s drug-device combination product includes a controlled formulation of cantharidin (0.7% w/v) delivered via single-use applicator for topical dosing and targeted administration. Its NDA is supported by findings from a pair of phase 2 clinical trials showing a greater rate of patients treated with VP-102 achieved complete molluscum lesion clearance and lesion count reduction versus vehicle at 84 days (P <.0001).²

The most common adverse events observed in participants receiving VP-102 included application site blistering, pruritus, pain and erythema.

Verrica originally submitted VP-102’s application to the FDA for this indication in 2021, receiving a Complete Response Letter (CRL) due to observed deficiencies at the facility of a contract manufacturing organization (CMO) not involved with the drug’s manufacturing.³ The company stressed in the CRL announcement that the FDA did not identify any deficiencies associated with the drug’s clinical, safety or manufacturing properties.

Molluscum contagiosum currently affects about 6 million people in the US, though the highly contagious disease is most common in children. Along with this indication, VP-102 is currently being investigated in a pair of phase 2 clinical trials to treat common warts and external genital warts.

References

1. ^{Verrica Pharmaceuticals Announces FDA Acceptance of Filing of Resubmitted NDA for VP-102 for the Treatment of Molluscum Contagiosum. News release. Verrica Pharmaceuticals. February 27, 2023. https://verrica.com/press_release/fda-accepts-resubmitted-filing-for-vp-102-for-the-treatment-of-molluscum-contagiosum/}
2. ^{Eichenfield LF, Siegfried E, Kwong P, et al. Pooled Results of Two Randomized Phase III Trials Evaluating VP-102, a Drug-Device Combination Product Containing Cantharidin 0.7% (w/v) for the Treatment of Molluscum Contagiosum. Am J Clin Dermatol. 2021;22(2):257-265. doi:10.1007/s40257-020-00570-8}
3. ^{Kunzmann K. Verrica Receives CRL from FDA for Molluscum Drug VP-102 Application. HCPLive. September 20, 2021. Accessed February 28, 2023. https://www.hcplive.com/view/verrica-crl-fda-molluscum-drug-vp-102-application}