• 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

Janssen submits NDA for esketamine nasal spray

Johnson & Johnson subsidiary Janssen Pharmaceutical has submitted an NDA for esketamine nasal spray for the treatment of treatment-resistant depression in adults, the company said. Janssen said that it plans to submit an MAA to the EMA for esketamine nasal spray for the same indication later this year.

In May 2018, Janssen published positive results from a Phase 3 study of the esketamine nasal spray. According to the company, the NDA is supported by data from 5 Phase 3 studies in treatment-resistant depression patients, including 3 short-term studies, a withdrawal study, and a long-term safety study.

The esketamine nasal spray has received Breakthrough Therapy designation for this indication and for major depressive disorder with imminent risk for suicide.

Janssen Research & Development Global Head Mathai Mammen commented, “Of the nearly 300 million people who suffer from major depressive disorder worldwide, about one-third do not respond to currently available treatments. This represents a major unmet public health need. We are committed to working with the FDA to bring this new treatment option to US patients with treatment-resistant depression and to the medical community.”

Read the Janssen Pharmaceutical press release.

Share

published on September 4, 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
    Aptar Pharma banner
    © 2025 OINDPnews