Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum

Rhea-AI Summary

Verrica Pharmaceuticals (Nasdaq: VRCA) has resubmitted the New Drug Application (NDA) for VP-102, aimed at treating molluscum contagiosum, to the FDA. This resubmission addresses deficiencies noted in the Complete Response Letter from September 2021, including inspection issues and user interface recommendations. CEO Ted White anticipates a 2-month review period, with a potential launch of VP-102 as the first FDA-approved treatment for this viral skin disease affecting six million people, primarily children, in the U.S. annually.

Positive

• Resubmission of NDA for VP-102 addresses previous FDA deficiencies.
• If approved, VP-102 could be the first FDA-approved treatment for molluscum contagiosum.
• Verrica is prepared for a quick product launch following potential FDA approval.

Negative

• Resubmission is a response to previously identified FDA deficiencies, indicating prior setbacks.
• Uncertainty surrounding FDA approval timeline and potential market entry.

WEST CHESTER, Pa., Nov. 29, 2021 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it has resubmitted the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum) to the U.S. Food and Drug Administration (FDA).

The resubmission is limited to those sections and elements of the NDA that were identified as deficiencies in the Complete Response Letter (CRL) issued by the FDA in September 2021. The resubmission addresses the successful resolution of inspection deficiencies identified at a contract manufacturing organization (CMO) in the CRL, as well as the recommendations included in the General Advice Letter received from the FDA that relate to VP-102’s user interface.  

“We look forward to the FDA’s review of the resubmission of our NDA for VP-102,” said Ted White, Verrica’s President and Chief Executive Officer. “Based on published guidance for the industry, we believe our resubmitted NDA qualifies as a Class I resubmission with a 2-month review. If approved, Verrica is well-prepared to launch VP-102 as the first FDA-approved treatment option for molluscum, a highly contagious viral skin disease affecting 6 million people, primarily children, in the U.S. each year.”

About VP-102

Verrica’s lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. If approved, VP-102 would be the first product approved by the FDA to treat molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. VP-102 would be marketed in the United States under the conditionally accepted brand name YCANTH™. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.

About Molluscum Contagiosum (Molluscum)

There are currently no FDA-approved treatments for molluscum, a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.

About Verrica Pharmaceuticals Inc.

Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s late-stage product candidate, VP-102, is in development to treat molluscum, common warts and external genital warts, three of the largest unmet needs in medical dermatology. Verrica is also developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. The Company has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize LTX-315 for dermatologic oncology conditions. For more information, visit www.verrica.com.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include expectations regarding the Verrica’s expectations with regard to the resubmitted NDA qualifying as a Class I resubmission, the timing of the FDA review of the resubmitted NDA, the potential approval of the NDA for VP-102 and the potential benefits and potential commercialization of VP-102 for the treatment of molluscum, if approved, and the clinical development of Verrica’s VP-102 for additional indications and Verrica’s other product candidates. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, Verrica’s reliance on third parties over which it may not always have full control, uncertainties related to the COVID-19 pandemic and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2020 and other filings Verrica makes with the U.S. Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

FOR MORE INFORMATION, PLEASE CONTACT:

Investors:

Terry Kohler
Chief Financial Officer
484.453.3296
info@verrica.com 

William Windham
Solebury Trout
646.378.2946
wwindham@soleburytrout.com 

Media:

Zara Lockshin
Solebury Trout
646.378.2960
zlockshin@soleburytrout.com 

FAQ

What is the latest update on Verrica Pharmaceuticals (VRCA) regarding VP-102?

Verrica has resubmitted its NDA for VP-102 to the FDA, addressing previous deficiencies.

When will the FDA review the NDA resubmission for VP-102 by VRCA?

Verrica anticipates a 2-month review period for the NDA resubmission.

What is molluscum contagiosum, and how many people does it affect?

Molluscum contagiosum is a viral skin disease affecting approximately six million people in the U.S., primarily children.

What could VP-102 achieve if approved by the FDA?

If approved, VP-102 would be the first FDA-approved treatment option for molluscum contagiosum.

What were the deficiencies noted in the FDA's Complete Response Letter for VP-102?

The deficiencies included inspection issues at a contract manufacturing organization and recommendations on the product's user interface.