Epoladerm (1.3% diclofenac epolamine) / Virpax Pharma - LARVOL DELTA

Virpax Pharmaceuticals Engages Destum Partners to Direct Strategic Global Partnering Efforts (Businesswire) - “Virpax® Pharmaceuticals, Inc…today announced that the Company has engaged Destum Partners, Inc. to serve as the exclusive advisor for the Company's partnering and licensing efforts in strategic global markets. This initial engagement will encompass the Company’s two over-the-counter (OTC) product candidates, Epoladerm™, indicated for osteoarthritis pain and AnQlar™, an intranasal mucosal viral barrier.”

Licensing / partnership • Immunology • Osteoarthritis • Pain • Rheumatology

Virpax Pharmaceuticals Engages Destum Partners to Direct Strategic Global Partnering Efforts (Businesswire) - “Virpax® Pharmaceuticals, Inc…today announced that the Company has engaged Destum Partners, Inc. to serve as the exclusive advisor for the Company's partnering and licensing efforts in strategic global markets. This initial engagement will encompass the Company’s two over-the-counter (OTC) product candidates, Epoladerm™, indicated for osteoarthritis pain and AnQlar™, an intranasal mucosal viral barrier.”

Licensing / partnership • CNS Disorders • Immunology • Osteoarthritis • Pain • Rheumatology

Virpax Pharmaceuticals Reports 2022 Second Quarter Results and Recent Developments (Businesswire) - "Research and development expenses were approximately $3.3 million in the quarter compared to approximately $0.3 million from the prior year’s second quarter. The increase in research and development expenses was primarily attributable to an increase in preclinical activities for AnQlar, Probudur and Epoladerm, a milestone payment related to VRP324, and a slight increase in preclinical and regulatory activities for Envelta."

Commercial • CNS Disorders • Epilepsy

Virpax Will Pursue Direct to OTC Pathway for Epoladerm for Pain Associated with Osteoarthritis (Businesswire) - "Virpax® Pharmaceuticals, Inc...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....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."

FDA event • CNS Disorders • Musculoskeletal Pain • Osteoarthritis • Pain

Virpax Selects Kindeva Drug Delivery as Development Partner (Contract Pharma) - "Virpax Pharmaceuticals and Kindeva Drug Delivery have entered a partnership to work together to advance the clinical program of the Virpax-developed Diclofenac topical spray film (Epoladerm) in the U.S. The product is being studied for the treatment of pain associated with osteoarthritis of the knee. Using Kindeva’s state-of-the-art facilities located in Woodbury, MN, they will bring this product from an existing lab-scale formulation to a phase II and III clinical supply."

Licensing / partnership • CNS Disorders • Musculoskeletal Pain • Osteoarthritis • Pain

Virpax Pharmaceuticals Reports 2021 Year-End Results (Businesswire) - Virpax Pharmaceuticals, Inc...today announced its financial results for the twelve months ended December 31, 2021, and other recent developments....Research and development expenses increased by $3.5 million, or 275%, to $4.8 million for the year ended December 31, 2021, from $1.3 million for the year ended December 31, 2020. The increase was primarily attributable to...increases in pre-clinical activity related to Epoladerm of $1.2 million..."

Commercial • CNS Disorders • Osteoarthritis • Pain

Virpax Completes All FDA-Required Pre-Clinical Studies for Epoladerm (Businesswire) - "Virpax® Pharmaceuticals, Inc...completed all FDA required pre-clinical studies for Epoladerm™, Virpax’s investigational pre-filled topical spray analgesic product to manage chronic pain associated with osteoarthritis (OA) of the knee. The key Investigational New Drug Application (IND)-enabling studies completed included dermal toxicity, sensitization, irritation, phototoxicity and PK characteristics. Virpax is drafting FDA IND submission documents for Epoladerm that will include these pre-clinical studies....The pilot study will take place in Canada under a Clinical Trial Application (CTA) filing with enrollment of the first patient anticipated in 2022. Virpax plans to submit the results of the pilot study as part of its IND application."

Enrollment open • New trial • Preclinical • CNS Disorders • Musculoskeletal Pain • Osteoarthritis • Pain

"$VRPX Virpax Completes All FDA-Required Pre-Clinical Studies for Epoladerm™ https://t.co/tYr1jIZz2Z" (@stock_titan)

Virpax Successfully Completes Preclinical Dermal Safety Studies for Epoladerm (Businesswire) - "Virpax® Pharmaceuticals, Inc...reported positive results of four preclinical dermal safety studies for Epoladerm™ (diclofenac epolamine)....From these recently concluded animal studies, researchers concluded that once daily dermal administration of Epoladerm for 28 days was well-tolerated with no serious adverse findings. The studies were performed by Charles River Laboratories, a well-known clinical research organization. The studies included a skin irritation study in rabbits; a dermal sensitization assessment in guinea pigs; and a phototoxicity assay in mouse fibroblasts. Epoladerm was well- tolerated in each of the studies and no reportable dermal irritation, dermal sensitization or phototoxicity was observed."

Preclinical • CNS Disorders • Musculoskeletal Pain • Osteoarthritis • Pain

"Virpax® Successfully Completes Preclinical Dermal Safety Studies for Epoladerm™ https://t.co/cu6AHblLSv" (@NewsFromBW)

Virpax Announces Clinical Trial Site in Canada for First in Human Study of Epoladerm for Pain Associated with Osteoarthritis of the Knee (Businesswire) - "Virpax® Pharmaceuticals, Inc...signed a clinical trial agreement with Altasciences Company, Inc...for a First in Human study investigating Epoladerm™ for pain associated with osteoarthritis of the knee. The study will take place in Canada with a CTA filing and enrollment of the first patient anticipated by Q2 of 2022."

Licensing / partnership • New trial • CNS Disorders • Osteoarthritis • Pain

Virpax Reports Successful Results of Toxicology and Pharmacokinetic Study for Epoladerm (Businesswire) - "Virpax Pharmaceuticals...reported positive results following the completion of a toxicology and pharmacokinetic study designed to support clinical trials with Epoladerm™, one of its lead investigational product candidates for the management of pain associated with osteoarthritis of the knee...a renowned CRO engaged by Virpax to perform Food and Drug Administration (FDA) required pre-clinical studies, has completed a single dose pharmacokinetic study of dermal administration of Epoladerm in minipigs as part of the required Investigational New Drug Application ('IND') enabling trials....This data should strengthen the Company’s IND filing in advance of the anticipated start of first-in-human clinical trials."

Preclinical • CNS Disorders • Osteoarthritis • Pain

Virpax Pharmaceuticals Provides Progress Update on Product Candidates (Businesswire) - "Epoladerm....The Company will begin a series of IND enabling toxicity studies which are expected to take from eight months to one year to complete. Upon successful completion of these studies, the Company intends to submit an IND application to the FDA, including a trial design for a Phase I study....For the chronic osteoarthritis pain of the knee indication, Virpax is planning to conduct a Phase I study to evaluate the relative bioavailability, pharmacokinetics, and safety of its product candidate, OSF200, compared with Pennsaid topical solution. No date for trial initiation or timeline has been determined for OSF200 at this time."

IND • Preclinical • CNS Disorders • Musculoskeletal Pain • Pain

Virpax to Initiate Investigational New Drug (IND) Enabling Studies for Epoladerm(TM) (BioSpace) - "Virpax Pharmaceuticals...today announced that it has signed an agreement with Charles River Laboratories to initiate preclinical studies of Epoladerm™...for acute musculoskeletal pain....'We recently completed our initial public offering with the expectation that the funds raised would be used to further our product candidate pipeline and move through preclinical studies into clinical trials'....'Upon completion of these preclinical studies, we anticipate filing our IND briefing documents in the first half of 2021.'"

IND • Licensing / partnership • Musculoskeletal Pain • Pain