FDA Accepts New VP-102 Application for Molluscum Contagiosum

Verrica Pharmaceutical's drug-device combination will be decided upon as potentially the first molluscum drug in July.

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