• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 25
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 25
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Hygienic Packaging Technology

    Trends in Solid Oral Dosage Delivery

    5 Reasons Paper Has No Place in Contract Manufacturing

    Injectable Drug Delivery Trends

    Pharmaceutical Manufacturing Equipment Trends
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    Amgen to Acquire Five Prime Therapeutics for $1.9B

    Genesis Drug Discovery & Development Acquires Integrated Analytical Solutions

    CureVac, Novartis Ink COVID Vax Mfg. Pact

    Innoforce and dMed Enter Development Collaboration

    Matica Biotechnology Breaks Ground on Cell and Gene Therapy Site
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    Reed-Lane Facility Virtual Tour

    CureVac, Novartis Ink COVID Vax Mfg. Pact

    Matica Biotechnology Breaks Ground on Cell and Gene Therapy Site

    WuXi AppTec Completes OXGENE Acquisition

    Trends in Solid Oral Dosage Delivery
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Reed-Lane Facility Virtual Tour

    Hygienic Packaging Technology

    Reshaping the Pharmaceutical Supply Chain

    Serialization: Level 5 Solution

    Covectra Introduces Next-Gen Serialization Solution
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Genesis Drug Discovery & Development Acquires Integrated Analytical Solutions

    Innoforce and dMed Enter Development Collaboration

    Matica Biotechnology Breaks Ground on Cell and Gene Therapy Site

    Four Female Leaders Appointed to Cell & Gene CDMO

    Strata Oncology Unveils Strata PATH Trial
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Guide to Maintaining Validation of Older Facilities: Why, When and How

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

    Top BioPharma Form Accumulus Synergy

    Global Biosciences Co. Selects ValGenesis VLMS

    Gene Therapy Co. Selects ValGenesis' SaaS Platform
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Alcami

    Adare Pharma Solutions

    PCI Pharma Services

    Baxter BioPharma Solutions

    Syngene
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Alcami

    Syngene

    PCI Pharma Services

    Reed-Lane

    Adare Pharma Solutions
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • Podcasts
    • White Papers
    • Infographics
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Breaking News

    Virpax Completes pre-IND Meeting with FDA

    Epoladerm spray being developed with contract service company MedPharm

    Virpax Completes pre-IND Meeting with FDA
    Contract Pharma Staff05.22.20
    Virpax Pharmaceuticals, a company specializing in developing pharmaceutical products for pain management by using new drug delivery systems, successfully completed a pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) for Epoladerm (diclofenac epolamine) spray. Epoladerm is being developed in partnership with MedPharm, a contract provider of topical and transdermal product design and formulation development services. Epoladerm is an investigational metered-dose topical aerosol of diclofenac epolamine supplied in a pre-filled device for administration as a topical spray film to the area of osteoarthritis of the knee.
     
    In the meeting, the FDA agreed that it is reasonable for Virpax to pursue a 505(b)(2) New Drug Application (NDA) for Epoladerm, which is an abbreviated approval pathway allowing Virpax to reference safety and efficacy data of a reference listed drug. It was further indicated that the planned indication for Epoladerm osteoarthritis of the knee is acceptable. Other guidance regarding study design was also provided.
     
    MedPharm is working closely with Virpax to develop Epoladerm (NSAID spray film) an investigational spray film designed to deliver an NSAID transdermally via a metered-dose spray. The delivery system features a high level of adhesiveness, accessibility and skin drying and is based on MedPharm’s unique MedSpray technology.
     
    “MedSpray’s unique characteristics of optimal dosing and patient convenience offers clients new opportunities to develop products with existing actives to benefit patients,” said Prof. Marc Brown, MedPharm’s co-founder and chief scientific officer.
     
    Given this feedback, Virpax is now planning for a Phase I pharmacokinetic study of Epoladerm in humans. “We believe our proprietary metered-dosed delivery system could provide an effective tool in the management of osteoarthritis of the knee,” said Anthony P. Mack, chief executive officer, Virpax. “We are looking forward to moving ahead with our planned studies and executing on our clinical milestones given this accelerated regulatory pathway.”
    Related Searches
    • Drug Delivery

    Related Breaking News

    • Breaking News | Collaborations & Alliances | Drug Delivery | Industry News | Information Technology | Solid Dosage/Semi-solids
      AARDEX Group Partners with Pill Connect

      AARDEX Group Partners with Pill Connect

      Links AARDEX’s proprietary Medication Event Monitoring System with Pill Connect’s add-on solutions for drug delivery devices.
      Charles Sternberg, Assistant Editor 02.04.21

    • Breaking News | Drug Delivery | Industry News
      Recipharm, Medspray Launch Resyca JV

      Recipharm, Medspray Launch Resyca JV

      To develop and exploit the softmist spray nozzle technology for pharmaceutical applications.
      Kristin Brooks 02.01.21

    • Breaking News | cGMP Manufacture | Collaborations & Alliances | Drug Delivery | Facilities | Industry News | Solid Dosage/Semi-solids
      Catalent Acquires Acorda’s INBRIJA Manufacturing Operations

      Catalent Acquires Acorda’s INBRIJA Manufacturing Operations

      The CDMO pays $80 million for dry powder inhaler spray drying, capsule manufacturing and packaging operations in Boston area.
      Contract Pharma Staff 01.13.21


    • Biologics, Proteins, Vaccines | Breaking News | Drug Delivery | Industry News
      iosBio Inks Exclusive Vax Platform Pact for COVID-19

      iosBio Inks Exclusive Vax Platform Pact for COVID-19

      OraPro oral delivery vaccine platform technology enables oral administration of thermally-stable, viral vector vaccines.
      Contract Pharma Staff 01.12.21

    • Breaking News | Cytotoxics and High Potency Manufacturing | Drug Delivery | Facilities | Industry News
      Inhalation CDMO Vectura Expands HPAPI Capabilities

      Inhalation CDMO Vectura Expands HPAPI Capabilities

      New facility will increase containment operations at Chippenham, UK site.
      Contract Pharma Staff 12.14.20

    • Drug Delivery | Industry News
      Recipharm, Medspray Establish JV

      Recipharm, Medspray Establish JV

      To exploit novel softmist technology for pharmaceutical applications.
      Contract Pharma Staff 11.17.20


    • Breaking News | Drug Delivery | Drug Development | Industry News
      Novo Nordisk to Acquire Emisphere Technologies

      Novo Nordisk to Acquire Emisphere Technologies

      Gains the Eligen SNAC oral delivery technology.
      Contract Pharma Staff 11.13.20

    • Breaking News | Collaborations & Alliances | Drug Delivery | Industry News | Parenterals
      Ypsomed Collaborates with Schott and Lonza

      Ypsomed Collaborates with Schott and Lonza

      Aims to deliver a comprehensive solution for wearable patch injectors.
      Contract Pharma Staff 11.10.20

    • Drug Delivery | Drug Development | Trials & Filings
      Impel NeuroPharma Submits NDA for INP104 in Acute Migraine

      Impel NeuroPharma Submits NDA for INP104 in Acute Migraine

      Leverages the company’s Precision Olfactory Delivery technology
      11.09.20


    • Biologics, Proteins, Vaccines | Breaking News | Drug Delivery | Industry News
      HHS Funds Development of Needle-free Vax Technology

      HHS Funds Development of Needle-free Vax Technology

      Patch could administer vaccines without traditional needles reducing the need for refrigeration in transport and storage, and possibly self-administration.
      Contract Pharma Staff 10.07.20

    • Breaking News | Drug Delivery | Industry News | Solid Dosage/Creams/Ointments
      Evonik Launches New Oral Drug Delivery Technology

      Evonik Launches New Oral Drug Delivery Technology

      For enteric protection and rapid release in the upper small intestine.
      Contract Pharma Staff 10.06.20

    • Breaking News | Collaborations & Alliances | Drug Delivery | Industry News
      Stevanato Group and Bexson Biomedical Collaborate

      Stevanato Group and Bexson Biomedical Collaborate

      Will develop a wearable drug delivery device for Bexson’s proprietary ketamine formulation.
      Contract Pharma Staff 09.22.20


    • Breaking News | Drug Delivery | Industry News
      Lubrizol Supports Women’s Health Worldwide

      Lubrizol Supports Women’s Health Worldwide

      Awarded grant for generic contraceptive injection research to advance women’s health around the globe.
      Contract Pharma Staff 09.16.20

    • Breaking News | Drug Delivery | Industry News | Solid Dosage/Creams/Ointments
      Colorcon Launches Acryl-EZE II

      Colorcon Launches Acryl-EZE II

      Extends pH range of enteric coatings for pharmaceutical use.
      Contract Pharma Staff 07.17.20

    • Breaking News | Collaborations & Alliances | Drug Delivery | Drug Development | Industry News
      Vectura Signs Agreement with Aerami Therapeutics

      Vectura Signs Agreement with Aerami Therapeutics

      Will support the development of imatinib for the treatment of Pulmonary Arterial Hypertension
      Contract Pharma Staff 06.08.20

    Trending
    • Catalent Acquires Delphi Genetics
    • Four Female Leaders Appointed To Cell & Gene CDMO
    • Matica Biotechnology Breaks Ground On Cell And Gene Therapy Site
    • Celonic Group Announces Plans For New Facility In Switzerland
    • BMS Expands Cell Therapy Manufacturing Capabilities
    Breaking News
    • Amgen to Acquire Five Prime Therapeutics for $1.9B
    • Genesis Drug Discovery & Development Acquires Integrated Analytical Solutions
    • CureVac, Novartis Ink COVID Vax Mfg. Pact
    • Innoforce and dMed Enter Development Collaboration
    • Matica Biotechnology Breaks Ground on Cell and Gene Therapy Site
    View Breaking News >
    CURRENT ISSUE

    March 2021

    • Hygienic Packaging Technology
    • Trends in Solid Oral Dosage Delivery
    • 5 Reasons Paper Has No Place in Contract Manufacturing
    • Injectable Drug Delivery Trends
    • Pharmaceutical Manufacturing Equipment Trends
    • Oral Solids: Market & Technology Trends
    • Nutraceutical Manufacturing: Meeting the Challenges of Today, Planning for Tomorrow
    • 2021 Contract Manufacturing Survey
    • Small Molecule Development Trends
    • Challenges & Opportunities Facing Small & Emerging Biopharma Companies
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    IFT Transitions 2021 Annual Event to Digital Experience
    NY Federal Judge Enters Permanent Injunction Against Dietary Supplement Manufacturer
    Statins May Contribute to Vascular Calcification by Inhibiting Vitamin K-Dependent Proteins
    Coatings World

    Latest Breaking News From Coatings World

    Chromaflo Technologies Adds Benjamin Woeste as Territory Sales Manager
    Maroon Group Acquires Cary Company's Raw Materials, Specialty Chemicals Distribution Business
    Matt Fogel Named Mule-Hide's Territory Manager – Southern Virginia
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    EchoNous Expands Its Kosmos Hardware Platform
    Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib
    Europe's Cross-Border Medtech Deal Activity Rises in Q4 2020
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Amgen to Acquire Five Prime Therapeutics for $1.9B
    Genesis Drug Discovery & Development Acquires Integrated Analytical Solutions
    CureVac, Novartis Ink COVID Vax Mfg. Pact
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Estée Lauder Establishes Equity and Engagement Center of Excellence
    L'Oreal On How It Will Shape Beauty's Future at Today's Transparency Summit
    C.O. Bigelow Earns Praise as NYC's Oldest Family-Run Apothecary
    Happi

    Latest Breaking News From Happi

    Avon Launches Vegan Skin Care Line
    Inolex Appoints VP Marketing
    Decorté Launches AI Diagnostics in US
    Ink World

    Latest Breaking News From Ink World

    Massilly North America Adds Koenig & Bauer MetalStar 3 Metal Decorating Press
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Access Direct Mail Doubles Revenue with SCREEN's Truepress Jet520HD
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Henkel publishes 30th Sustainability Report
    Avery Dennison Smartrac launches new Circus Pro inlays
    Springfield Solutions highlights digital label embellishments
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    FPInnovations Develops Biodegradable Mask
    Sani Professional Sanitizing and Disinfecting Products Approved by EPA
    Autefa Solutions Offers Fully Automated Line for Protective Mask Production
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Bioventus Appoints Managing Director, China and Asia Pacific
    Full-Year Sales Down 12 Percent at Zimmer Biomet
    Lincotek Medical Expands Coatings and Additive Capacity
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View Research

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login