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

OINDPnews


Intertek 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 announces positive results from PK study of OPNT003 intranasal nalmefene

Opiant Pharmaceuticals said that a PK study of its OPNT003 intranasal nalmefene, which it is developing for opioid overdose, demonstrated that the Tmax of the nasal formulation was about 15 minutes, similar to that shown in a previous pilot study, and Cmax was slightly higher than for an intramuscular injection of nalmefene and higher than in the pilot study. The study enrolled 68 subjects and evaluated a 3 mg dose of OPNT003 to a 1 mg dose of IM nalmefene.

The company also said that it initiated a PD study in April 2021 that is comparing OPNT003 to intranasal naloxone for the reversal of respiratory depression caused by remifentanil. Top line data from that study are expected to be available in the fourth quarter of 2021, and the company said that it expects to submit a 505(b)(2) NDA for OPNT003 at the end of 2021 or in the first quarter of 2022.

OPNT003 is formulated with Intravail absorption enhancer, which Opiant licensed from Aegis Therapeutics in 2017. In October 2020, Opiant announced that it was switching the delivery device for the product from Bespak’s Unidose Xtra to the Unit Dose System (UDS) from Aptar Pharma. Funding for development of the nasal spray has been provided by the National Institute on Drug Abuse and the Biological Advance Research and Development Agency. (BARDA).

Opiant President and CEO Roger Crystal commented, “We are very pleased with the results of this confirmatory PK study. Importantly, the data are consistent with the findings of our initial pilot study. In the United States, where we’ve seen the opioid epidemic worsen during COVID-19, the nationwide spread of potent illicit synthetic opioids, such as fentanyl, which is 50 times stronger than heroin, with a half-life more than seven hours, is driving significant numbers of opioid overdose deaths. A rescue agent with a rapid onset and a long half-life, is critical to saving lives from overdose. We now look forward to the PD data later in the year.”

Read the Opiant Pharmaceuticals press release.

Share

published on July 8, 2021

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
    Merxin We Make Inhalers banner
    © 2025 OINDPnews