FDA denies approval of Verrica’s molluscum contagiosum treatment
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The FDA denied approval to Verrica Pharmaceuticals’ molluscum contagiosum treatment VP-102, the company announced in a press release.
A complete response letter to Verrica’s new drug application listed deficiencies found during an inspection of Sterling Pharmaceuticals Services, a contract manufacturing organization (CMO) where the drug’s bulk solution is produced. The deficiencies resulted in an official action indicated (OAI) status, the FDA’s most serious violation category.
The issues defined by the FDA were not specific to the manufacturing of VP-102.
“Based on the successful [pre-approval inspection] of VP-102 at Sterling and our understanding that the division was ready to communicate our label, we believe our NDA meets the statutory standards for approval and that any issues at Sterling do not impact the manufacturing, quality, efficacy or safety of VP-102,” Ted White, president and CEO of Verrica, said in the release. “However, we recognize that the dermatology division’s hands may be tied due to the reinspection issues at Sterling and thank them for their efforts working with us to date.”
Molluscum contagiosum, a highly contagious viral skin disease, is caused by a pox virus. There are no treatments currently approved for molluscum.
VP-102, a drug-device combination product that contains a GMP-controlled formulation of cantharidin delivered with a single use applicator, is in development for the treatment of molluscum, common warts and external genital warts.
“VP-102 is a non-sterile topical dermatology product that is not systemically absorbed. It is completely solvent based and has been demonstrated to have bactericidal and viricidal properties. By comparison, the observations cited at Sterling which led to its OAI classification status were predominantly related to its distinct sterile operations where higher-risk, sterile ophthalmic products are manufactured by Sterling for, among other distributors, the U.S. government,” White said.
Verrica is working with Sterling to present options to the FDA and is engaging an additional CMO as an alternative supplier of VP-102’s bulk solution.