Virpax Will Pursue Direct to OTC Pathway for Epoladerm™ for Pain Associated with Osteoarthritis

Rhea-AI Summary

Virpax Pharmaceuticals (NASDAQ: VRPX) announced its decision to pursue a direct OTC regulatory pathway for Epoladerm™, intended to treat osteoarthritis pain. This approach is expected to expedite drug development and approval compared to the initial prescription route. To support the OTC submission, Virpax will submit various studies to the FDA, including dermal toxicity and consumer preference assessments. CEO Anthony Mack emphasizes Epoladerm's potential for convenient dosing. The company intends to validate its claims across North America, Europe, and Asia.

Positive

• Pursuing a direct OTC regulatory pathway for Epoladerm may expedite drug development and approval timelines.
• Epoladerm's once or twice daily spray dosing offers a more convenient alternative to current treatments.

Negative

• The need for additional studies, such as consumer preference assessments, may prolong the overall regulatory process.
• The shift from prescription to OTC may indicate challenges in the initial clinical development strategy.

BERWYN, Pa.--(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.

View source 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

Source: Virpax Pharmaceuticals

FAQ

What is the significance of Virpax's decision to pursue an OTC pathway for Epoladerm?

The OTC pathway is expected to expedite the drug development timeline and global approval process for Epoladerm, aimed at treating osteoarthritis pain.

What studies does Virpax need to complete for Epoladerm's OTC submission?

Virpax plans to submit dermal toxicity, sensitization, irritation, phototoxicity studies, and conduct a consumer preference assessment for Epoladerm.

How does Epoladerm compare to existing OTC pain treatments?

Epoladerm offers a more convenient dosing method, requiring administration once or twice daily, compared to the four times daily application of current topical diclofenac gels.

What is the expected market focus for Epoladerm?

Virpax aims to validate Epoladerm's claims and address markets in North America, Europe, and Asia.

What is the stock symbol for Virpax Pharmaceuticals?

The stock symbol for Virpax Pharmaceuticals is VRPX.