Virpax Will Pursue Direct to OTC Pathway for Epoladerm™ for Pain Associated with Osteoarthritis
June 27 2022 - 9:00AM
Business Wire
Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”)
(NASDAQ: VRPX), a company specializing in developing
non-addictive products for pain management, post-traumatic stress
disorder, central nervous system (CNS) disorders and anti-viral
indications, today announced that it will pursue a direct to OTC
regulatory pathway for Epoladerm™, the Company’s product candidate
to treat pain associated with osteoarthritis.
The direct to OTC, non-prescription regulatory pathway is
expected to provide a faster drug development timeline and faster
global approval track than the prescription pathway the Company had
originally pursued for Epoladerm. To support the OTC application,
the Company plans to submit Epoladerm’s completed dermal toxicity,
sensitization, irritation, phototoxicity studies and its PK
characteristics to FDA. In addition, Virpax anticipates it will
have to complete a consumer preference assessment and a pivotal
study required by the FDA’s Office of Non-prescription Drugs.
“We believe that Epoladerm’s potential once or twice daily spray
dosing may be a more efficient and convenient hands-free
alternative to the current OTC topical diclofenac gel which is
dosed four times a day by hand onto the skin,” stated Anthony P.
Mack, Chairman and CEO of Virpax. “Virpax intends to validate
Epoladerm’s claims and value in North America, Europe and Asia,”
Mack continued.
About Virpax Pharmaceuticals Virpax is developing
branded, non-addictive pain management products candidates using
its proprietary technologies to optimize and target drug delivery.
Virpax is initially seeking FDA approval for two prescription drug
candidates that employ two different patented drug delivery
platforms. Probudur™ is a single injection liposomal bupivacaine
formulation being developed to manage post-operative pain and
Envelta™ is an intranasal molecular-envelope enkephalin formulation
being developed to manage acute and chronic pain, including pain
associated with cancer. Virpax is also using its intranasal
Molecular Envelope Technology (MET) to develop two other product
candidates. PES200 is a product candidate being developed to manage
post-traumatic stress disorder (PTSD) and VRP324 is a product
candidate being developed for the nasal delivery of a
pharmaceutical-grade cannabidiol (CBD) for the management of rare
pediatric epilepsy. Virpax recently acquired global rights to
VRP324. Virpax is also seeking approval of two nonprescription
product candidates. AnQlar is being developed to inhibit viral
replication caused by influenza or SARS-CoV-2, and Epoladerm™ is a
topical diclofenac spray film formulation being developed to manage
pain associated with osteoarthritis. For more information, please
visit www.virpaxpharma.com.
Forward-Looking Statement This press release contains
certain forward-looking statements within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934 and Private Securities Litigation Reform Act,
as amended, including those relating to the Company's planned
clinical trials, product development, clinical and regulatory
timelines, market opportunity, competitive position, possible or
assumed future results of operations, business strategies,
potential growth opportunities and other statements that are
predictive in nature. These forward-looking statements are based on
current expectations, estimates, forecasts and projections about
the industry and markets in which we operate and management's
current beliefs and assumptions.
These statements may be identified by the use of forward-looking
expressions, including, but not limited to, "expect," "anticipate,"
"intend," "plan," "believe," "estimate," "potential,” "predict,"
"project," "should," "would" and similar expressions and the
negatives of those terms. These statements relate to future events
or the Company’s financial performance and involve known and
unknown risks, uncertainties, and other factors, including the
potential impact of the COVID-19 pandemic and the potential impact
of sustained social distancing efforts, on the Company’s
operations, clinical development plans and timelines, including any
switch to an OTC pathway for certain of the Company’s product
candidates, which may cause actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements. Such factors include those set forth in
the Company’s filings with the Securities and Exchange Commission.
Prospective investors are cautioned not to place undue reliance on
such forward-looking statements, which speak only as of the date of
this press release. The Company undertakes no obligation to
publicly update any forward-looking statement, whether as a result
of new information, future events or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20220627005164/en/
Christopher M. Chipman, CPA Chief Financial Officer
cchipman@virpaxpharma.com 610-727-4597
Or
Betsy Brod Affinity Growth Advisors
betsy.brod@affinitygrowth.com 212-661-2231
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