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

OINDPnews


H&T Presspart Low GWP Banner
  • 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

Opiant Pharmaceuticals developing intranasal nalmefene for the treatment of opioid overdose

Opiant Pharmaceuticals has announced that, based on feedback from the FDA and positive data from a Phase I clinical study, the company plans to pursue a 505(b)(2) development path for its OPNT003 intranasal nalmefene for the treatment of opioid overdose. OPNT003 is formulated using Aegis Therapeutics’ Intravail absorption enhancer, which Opiant licensed in 2017.

According to Opiant, a Phase 1 study of OPNT003 demonstrated that the intranasal formulation produced a faster onset than intramuscular injection with “rapid increases in plasma levels.” In addition, the company pointed out that the half-life of the intranasal formulation was 6.7-7.8 hours compared to 2 hours for an injection, which is in line with recent calls by NIH for longer-acting opioid antagonists.

The company also said that it has applied for a grant from the National Institutes of Health (NIH) to fund development of the product.

Opiant CEO Roger Crystal commented, “We are pleased with the positive outcome of this meeting and the beneficial guidance received from the FDA. We now have a well-defined development and regulatory pathway to pursue approval of OPNT003 in the US for the treatment of opioid overdose. Following the feedback received from the FDA, we are focused on leveraging the 505(b)(2) development pathway that allows certain information required for NDA approval to be derived from studies not conducted by Opiant. We anticipate submitting an NDA for OPNT003 in 2020. Based on its profile and the Phase I trial results, we believe OPNT003 has the potential to be a transformative treatment for opioid overdose, a growing US health epidemic.”

Adapt Pharma has marketed Opiant’s Narcan naloxone nasal spray for the reversal of opioid overdose in the US since 2016.

Read the Opiant press release.

Share

published on February 12, 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
    Bespak Leading the Green Transition banner
    © 2025 OINDPnews