Verrica Pharmaceuticals Announces Extension of FDA Review Period of its NDA for VP-102 for the Treatment of Molluscum Contagi...
May 28 2021 - 7:30AM
Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a
dermatology therapeutics company developing medications for skin
diseases requiring medical interventions, today announced that the
U.S. Food and Drug Administration (FDA) has extended the review
period for the New Drug Application (NDA) for VP-102 for the
treatment of molluscum contagiosum (molluscum). The Prescription
Drug User Fee Act (PDUFA) goal date has been extended by three
months to September 23, 2021.
The FDA extended the PDUFA goal date to allow the Agency to have
additional time to review information submitted by Verrica,
including its training program and distribution model, in response
to comments from the agency regarding the Company’s human factors
study. On May 26, 2021, the FDA informed Verrica that the
information submitted has been designated a major amendment, which
allows FDA to take an additional three months to review the
submitted information.
“We remain confident in VP-102 as a potential treatment option
for patients with molluscum,” said Ted White, Verrica’s President
and Chief Executive Officer. “Importantly, the FDA has recently
completed one of the two pre-approval inspections required for
approval. We look forward to our continued productive discussions
with the FDA as it completes its review of our VP-102 NDA.”
About VP-102
Verricaʼs 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. VP-102 is currently under U.S. Food and Drug
Administration (FDA) review, with a PDUFA goal date of September
23, 2021, and could potentially 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. 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)
Molluscum is 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 Company’s expectations with regard to the PDUFA date
and potential approval of the NDA for VP-102 and the
potential benefits 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 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:
A. Brian DavisChief Financial
Officer484.453.3300 ext. 103info@verrica.com
William WindhamSolebury
Trout646.378.2946wwindham@soleburytrout.com
Media:
Zara LockshinSolebury
Trout646.378.2960zlockshin@soleburytrout.com
Verrica Parmaceuticals (NASDAQ:VRCA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Verrica Parmaceuticals (NASDAQ:VRCA)
Historical Stock Chart
From Apr 2023 to Apr 2024