• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to secondary sidebar

OINDPnews


Proveris Scientific
  • Home
  • News
    • Business
    • Features
    • Medical
    • Regulatory
    • Products and Services
    • People
  • Events
  • Suppliers
    • Supplier listing and advertising options
    • Capsules and blisters
    • Consultants
    • Contract research
    • Contract manufacturing
    • Devices
    • Education
    • Excipients
      • Clinical Technology
    • Filling equipment
    • Instruments
    • Particle manufacturing
    • Software and modeling
  • Jobs
  • Resources
    • Webinars
    • White papers
  • LGWP Propellants
    • HFA 152a
    • HFO-1234ze(E)
    • LGWP Regulation
  • Contact

MVP says it believes it can meet FDA requirements for Penthrox IND

Medical Developments International (MVP), which announced in July 2018 that it was expecting a clinical hold letter from the FDA regarding its US clinical program for its Penthrox methoxyflurane inhaler, said that it has now received the letter from the FDA and believes that the company can satisfy the FDA’s requirements.

According to MVP, the FDA is requiring the company to change the exclusion criteria for the Phase 1 study. MVP had proposed using healthy volunteers excluding those who had experienced hepatoxicity from either methoxyflurane or halothane previously. The agency wants the company “to identify an appropriate patient population . . . for whom the risk/benefit of Penthrox would be reasonable,” MVP said, along with providing more information regarding idiosyncratic hepatoxicity and justification of the risk of its occurrence, which MVP says is rare.

Some of the other information requested by the agency pertains to questions about the “whistle” delivery device, including the instructions for use, the amount of methoxyflurane captured in an activated carbon chamber that absorbs exhaled drug, and performance of the inhaler’s valve system.

MVP CEO John Sharman commented, “We are currently consulting with ourscientific team, USA and EU advisors on the development program needed to satisfy the FDA’s requirements. We will report back to the market as to the impact on costs and timeframes in due course.”

Penthrox is already approved in Australia, Canada, and most of Europe.

Read the MVP press release.

Share

published on August 30, 2018

Primary Sidebar

Sign up for our free weekly newsletter

Upcoming Events
Sponsored by Intertek

Want information about upcoming OINDP-related events delivered directly to your inbox? click here

  • June 17-June 18: Rescon Europe 2025, Paris, France
  • June 19-June 20: Metered Dose Inhaler (MDI) Technology Training Course, online
  • June 22-June 25: ISAM Congress 2025, Washington, DC, USA
  • June 25-June 25: SMI.London 2025, London, UK
  • September 18-September 19: IPAC-RS Nasal Innovation Forum, West Trenton, NJ, USA
  • See all upcoming events

    Secondary Sidebar

    Suppliers

    Capsules and blisters
    Consultants
    Contract research
    Contract manufacturing
    Devices
    Education
    Excipients
    Filling equipment
    Instruments
    Particle manufacturing
    Software and modeling
    Solstice Air banner
    © 2025 OINDPnews