Virpax Pursues OTC Medical Device Pathway for AnQlar™
Virpax Pharmaceuticals (NASDAQ: VRPX) has announced its decision to pursue an OTC Intranasal Medical Device pathway for AnQlar™, which aims to act as a prophylactic antiviral barrier against influenza and SARS-CoV-2. The company anticipates this regulatory route will expedite development and global approval compared to the previously sought OTC non-prescription New Drug Application. Virpax will submit various studies to the FDA regarding AnQlar, while also focusing on its other OTC candidate, Epoladerm™, and its prescription drug pipeline.
- Transitioning to an OTC Intranasal Medical Device pathway for AnQlar may expedite approval processes.
- Plans to include comprehensive studies to support FDA submission, which could enhance credibility.
- The development of a novel antiviral barrier product could capture significant market interest.
- None.
“We believe that AnQlar, upon successful development and commercialization, may be a 24-hour prophylactic medical device that can be used as an intranasal barrier against COVID, Influenza and most negatively charged viruses, including the Rhinovirus. We expect the OTC non-prescription Medical Device pathway to provide a faster drug development timeline and global approval track than the OTC non-prescription New Drug Application pathway that we had originally pursued for AnQlar,” stated
“Additionally, we intend to validate AnQlar’s claims and assess its value for commercialization in
To support the OTC Medical Device application, Virpax plans to submit AnQlar’s completed in-vitro study, ex-vivo study using human mucosal cells, in-vivo study in rats, toxicology study and its pharmacokinetics (PK) characteristics studies to the FDA. Additionally, the Company will include AnQlar’s completed safety-pharmacology studies, drug-drug interaction studies and its virology studies evaluating AnQlar’s antiviral properties against two variants of SARS-CoV-2 in a SARS-CoV-2 mouse model to the FDA. For the OTC medical device application, Virpax anticipates that it will have to complete stability testing, human factors testing for medical devices, safety studies and supplementary in-vitro studies.
About
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 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
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Chief Financial Officer
cchipman@virpaxpharma.com
610-727-4597
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