Verrica Pharmaceuticals, which is seeking approval for a medication to treat skin diseases, said the FDA issued a complete response letter detailing problems at a partner's facility manufacturing the treatment.
The West Chester, Pennsylvania-based company said the issues at the facility were not “specifically related” to the production of its lead drug VP-102. Regulators, however, did raise concerns over general quality issues.
Prior to the letter, Verrica had not received any communication from the FDA about problems at the unnamed facility or issues related to the production of VP-102, the company said. Additionally, the agency didn’t identify any clinical, safety or product specific issues related to VP-102.
VP-102 is a drug-device combination that consists of cantharidin and a device for applying the topical solution.
An investor note by RBC Capital Markets identified the contract manufacturer's site as being located in the St. Louis area.
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The CMO told Verrica it has taken corrective measures to address FDA concerns and expects a resolution of the issues in the next 30 days, the company said.
“We remain confident that we have a path forward for VP-102 as a potential treatment option for molluscum, a highly contagious viral skin disease affecting approximately six million people in the United States—primarily children—for which there are currently no FDA-approved treatments,” Ted White, Verrica president and CEO, said in a statement.
In May, the company said the FDA extended the goal date for the NDA by three months to Thursday in order to allow the agency more time to review information from Verrica in response to comments from the regulatory body regarding the company’s human factors study.
If it can gain approval, Verrica's drug could generate $300 million in peak sales, Jefferies analysts wrote on Monday.