– assigned PDUFA target date is June 23, 2021 –
– VP-102 (cantharidin 0.7% topical solution) could potentially be the first FDA-approved treatment for molluscum contagiosum, a highly contagious viral skin infection that affects approximately 6 million people in the United States, mostly children –
WEST CHESTER, Pa., February 17, 2021 (GLOBE NEWSWIRE) – Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutic company developing drugs for skin diseases requiring medical interventions, today announced that it has resubmitted New Drug Application (NDA) for VP-102 (cantharidin 0.7% topical solution), a patented topical therapy for the treatment of molluscum contagiosum (molluscum), has been accepted for filing by the U.S. Food and Drug Administration (FDA). The target date of the Prescription Drug User Fee Act (PDUFA) assigned by the FDA for this NDA is June 23, 2021.
Verrica previously filed an NDA for VP-102 for the treatment of molluscum in September 2019. As previously announced, the FDA issued a full response letter in July 2020 asking for additional information on Chemistry, Manufacturing and Controls (CMC) and Human Factors. validation is requested. Verrica re-submitted the NDA for VP-102 for the treatment of molluscum on December 23, 2020.
“This is an exciting time for Verrica as we work with the FDA to continue to guide the VP-102 through the regulatory process,” said Ted White, Verrica’s president and chief executive officer. “We believe VP-102 is well positioned to become the first FDA-approved product for the treatment of molluscum and could potentially bring relief to the millions of children diagnosed with this highly contagious disease.”
The NDA is based on positive results from two identical phase 3 randomized, double-blind, multicentre clinical trials (CAMP-1 and CAMP-2) that evaluated the safety and efficacy of VP-102 compared to placebo in patients aged two years and older diagnosed with molluscum. In both studies, a clinically and statistically significant number of patients treated with VP-102 achieved the primary endpoint of complete clearance of all treatable mollusk lesions.
VP-102 was well tolerated in both studies, no serious adverse events were reported in VP-102 treated subjects.
Verrica’s lead product candidate, VP-102, is a patented drug and device combination product containing a GMP controlled formulation of cantharidin (0.7% w / v) delivered via a single use applicator that provides accurate topical dosing. and allows targeted administration. VP-102 is currently under review by the United States Food and Drug Administration (FDA) and could potentially be the first product approved by the FDA for the treatment of molluscum contagiosum – a common, highly contagious skin disease that affects an estimated six million people. the United States. mainly children. If approved, VP-102 will 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 about six million people – mostly children – in the United States. Molluscum is caused by a smallpox virus that produces noticeably raised, skin-colored to pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or via fomites (objects that carry the disease, such as 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 parts of the body and can carry significant social stigma. Without treatment, molluscum can last an average of 13 months, and in some cases up to several years.
About Verrica Pharmaceuticals Inc.
Verrica is a dermatological therapeutic company that develops medicines for skin diseases that require medical intervention. Verrica’s late stage product candidate, VP-102, is under development for the treatment of molluscum contagiosum (molluscum), common warts and external genital warts, three of the greatest unmet needs in medical dermatology. Verrica is also developing VP-103, its second product candidate based on cantharidin, for the treatment of plantar warts. The company has also entered into a global licensing agreement with Lytix Biopharma AS to develop and commercialize LTX-315 for dermatological oncology conditions. For more information visit www.verrica.com
Any statements 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 can be identified by words such as “believe”, “expect,” “can”. , “plans”, “potential”, “will” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include expectations regarding the Company’s expectations regarding the potential approval of the NDA for VP-102 and the potential benefits and commercialization of VP-102 for the treatment of molluscum, if approved. These statements involve risks and uncertainties that could cause actual results to differ materially from those expressed in such statements. Risks and uncertainties that could cause actual results to differ materially include uncertainties inherent in the drug development process and regulatory approval process, Verrica’s dependence on third parties over which it may not always have full control, uncertainties related to to the COVID-19 pandemic and other risks and uncertainties described in Verrica’s annual report on Form 10-K for the year ended December 31, 2019, Verrica’s quarterly report on Form 10-Q for the quarter ended September 30, 2020, and other filings that Verrica makes with the United States Securities and Exchange Commission. All 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 press release, and Verrica assumes no obligation to update 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:
A. Brian Davis
484.453.3300 ext. 103
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