Verrica Pharmaceuticals Announces FDA Filing Acceptance of New Drug Application for VP-102 for the Treatment of Molluscum Con...
November 27 2019 - 7:00AM
Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a
medical dermatology company, today announced that its New Drug
Application (NDA) for VP-102 (cantharidin 0.7% Topical Solution), a
proprietary topical therapy for the treatment of molluscum
contagiosum (molluscum), has been accepted for filing by the U.S.
Food and Drug Administration (FDA). The Prescription Drug User Fee
Act (PDUFA) goal date assigned by the FDA for this NDA is July 13,
2020.
“There are no FDA-approved treatments currently available to
patients diagnosed with molluscum, the majority of whom are
children, leaving caregivers to choose between a wait-and-see
approach or treatments with unproven efficacy,” said Ted White,
President and Chief Executive Officer, Verrica. “Left untreated,
molluscum is easily transmitted, with lesions persisting an average
of 13 months, and molluscum can last up to several years, as seen
in our clinical trials. The acceptance of this NDA for review is
the next step toward bringing patients and their caregivers a safe
and effective topical therapy for this common, highly contagious
viral skin disease that carries a substantial social stigma. We
look forward to working closely with the FDA during this review
period.”
The NDA is based on positive results from two identical Phase 3
randomized, double-blind, multicenter clinical trials (CAMP-1 and
CAMP-2) that evaluated the safety and efficacy of VP-102 compared
to placebo in patients two years of age and older diagnosed with
molluscum. CAMP-1 was conducted under a SPA (Special
Protocol Assessment) with the FDA. In both trials, a
clinically and statistically significant number of patients treated
with VP-102 met the primary endpoint of complete clearance of all
treatable molluscum lesions.
VP-102 was well-tolerated in both trials, with no serious
adverse events reported in VP-102-treated subjects.
About Verrica Pharmaceuticals Inc.
Verrica is a medical dermatology company committed to the
development and commercialization of novel treatments that provide
meaningful benefit for people living with skin diseases. The
Company’s late-stage product candidate, VP-102, is a potential
first-in-class topical therapy for the treatment of molluscum
contagiosum and common warts. Molluscum is a highly contagious
viral skin infection affecting approximately six million people,
primarily children, in the United States, and common
warts are contagious skin growths affecting 22 million people.
There are currently no FDA-approved treatments for molluscum or
common warts. Following positive topline results from two pivotal
Phase 3 trials, the Company submitted an NDA on September 13, 2019
for VP-102 for the treatment of molluscum; on November 26, 2019,
the Company received notice that the FDA accepted the NDA for
filing with a PDUFA goal date of July 13, 2020. Verrica intends to
commence a Phase 3 trial in the first quarter of 2020 to evaluate
VP-102 for common warts. VP-102 is also currently in a Phase 2
trial for the treatment of external genital warts. A second product
candidate, VP-103, is in pre-clinical development for plantar
warts. For more information, visit www.verrica.com.
Forward-Looking Statement
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 potential benefits of VP-102 for the treatment of
molluscum and the clinical development of VP-102 for additional
indications, including common warts, external genital warts and
plantar warts. 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, and other risks and uncertainties
that are described in Verrica’s Annual Report on Form 10-K for the
year ended December 31, 2018, filed with the U.S.
Securities and Exchange Commission on March 7, 2019, 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 Davis Chief Financial Officer
484.453.3300 ext. 103 info@verrica.com
Chiara Russo Solebury Trout 617.221.9197
crusso@soleburytrout.com
Media:
Joshua R. Mansbach Solebury Trout 646-378-2964
jmansbach@troutgroup.com
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