Accessibility Statement Skip Navigation
  • Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All Public Company News
      • All Multimedia News
      • View All News Releases

      • Regulatory News

      • D/A/CH Regulatory News
      • UK Regulatory News
      • View All Regulatory News

  • Business & Money
      • Auto & Transportation

      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalisation
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls & Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defence
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers & Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines & Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics & Personal Care
      • Fashion
      • Food & Beverages
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewellery
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Overview
  • Distribution
  • Paid Placement
  • Multimedia
  • Disclosure Services
  • SocialBoost
  • Rooms
    • MediaRoom
    • ESG Rooms
  • AI Tools
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Hamburger menu
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO
    • Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • News in Focus
    • Browse News Releases
    • Regulatory News
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
    • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • Overview
  • Distribution
  • Paid Placement
  • Multimedia
  • Disclosure Services
  • Cision Communications Cloud®
  • AI Tools
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists

Orexo initiates new study of OX640 in participants with allergic rhinitis


News provided by

Orexo

25 Oct, 2024, 13:28 GMT

Share this article

Share toX

Share this article

Share toX

  • OX640 is an intranasal rescue medication for the treatment of severe allergic reactions (incl. anaphylaxis) with powder-based epinephrine.
  • OX640 is based on Orexo´s proprietary drug delivery platform, AmorphOX®, and has demonstrated positive data in a phase 1 clinical study in healthy volunteers.
  • The new study will investigate the performance of OX640 in participants with allergic rhinitis.

 UPPSALA, Sweden, Oct. 25, 2024 /PRNewswire/ -- Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), today announces the first participants have been dosed with OX640, an intranasal rescue medication for severe allergic reactions (incl. anaphylaxis) with powder-based epinephrine, in a new study in subjects with allergic rhinitis (hay fever). The study will be completed during 2024 with results available early in 2025.

Following the positive results from the phase 1 clinical study, OX640-001, where OX640 showed absorption of epinephrine and effects on blood pressure and heart rate equivalent to an epinephrine intramuscular auto-injector, Orexo now advances the development of OX640. In the new study, OX640-002, the epinephrine absorption from OX640 will be investigated in participants with and without allergic symptoms in the nose. As patients may experience allergic symptoms in the nose during anaphylaxis, it is critical to understand the absorption of epinephrine from Orexo's unique powder formulation under these conditions.

The study is a cross-over study in 30 participants with allergic rhinitis and involves four treatment periods. In one of the periods, a small dose of an allergen will be sprayed into the nose of the participants to trigger an allergic reaction before being treated with OX640. This will be compared with absorption of epinephrine from OX640 without the allergen, and a commercial intramuscular epinephrine product. The fourth period will be used to document dose proportionality of OX640. In addition to the absorption of epinephrine, effects on blood pressure and heart rate will be measured as relevant parameters to understand the effect of OX640 in case of an anaphylaxis.

Robert Rönn, SVP and Head of R&D, said: "Anaphylaxis is a serious and life-threatening condition, making it essential to ensure that OX640 remains effective even in the presence of nasal allergic symptoms. The study addresses key development and regulatory requirements and is an important step in advancing the project towards regulatory approval. The performance of OX640 under allergic rhinitis conditions has also been requested in many discussions with health care providers and with potential partners."

The study is expected to cost SEK 11 million. Most of these costs will be recognized in 2024 and are included in the communicated financial outlook for 2024. 

For further information:
Robert Rönn, SVP and Head of R&D
Lena Wange, IR & Communications Director
Nikolaj Sørensen, President and CEO
Tel: +46 (0)18 780 88 00
E-mail: ir@orexo.com

About AmorphOX® 

Orexo's proprietary drug delivery platform, AmorphOX, is a powder made up of particles which are built using a unique combination of a drug, carrier materials and, optionally, other ingredients. The particles are presented as an amorphous composite of the various ingredients providing for excellent chemical and physical stability, as well as rapid dissolution. The technology works for a broad scope of active ingredients and has been validated in several human clinical studies showing rapid and extensive drug exposure. 

About OX640

OX640 is an intranasal rescue medication for the treatment of severe allergic reactions (incl. anaphylaxis) with powder-based epinephrine. The product is based on Orexo´s proprietary drug delivery platform AmorphOX providing rapid and extensive systemic drug absorption after nasal administration as well as excellent physical and chemical stability. Thanks to its unique properties, OX640 has the potential to provide allergic patients with a needle-free, convenient, and rapidly acting allergy rescue product that also has long shelf-life and allows for flexible storage, both in hot and cold temperatures.

About OX640-001 

OX640-001 is a randomised sequence, single-centre, open label, 5-period crossover, phase 1 comparative bioavailability study with the primary objective to determine the relative bioavailability and absorption characteristics of four investigational formulations of OX640 versus an intramuscular auto-injector of epinephrine. 

About Orexo

Orexo is a Swedish pharmaceutical company with 30 years of experience developing improved pharmaceuticals based on proprietary formulation technologies that meet large medical needs. On the US market, Orexo provides innovative treatment solutions for patients suffering from opioid use disorder and adjacent diseases. Products targeting other therapeutic areas are developed and commercialized worldwide with leading partners. Total net sales in 2022 amounted to SEK 624 million, and the number of employees to 126. Orexo is listed on Nasdaq Stockholm's main list and is available as an ADR on OTCQX (ORXOY) in the US.

For more information about Orexo please visit, www.orexo.com. You can also follow Orexo on X, LinkedIn, and YouTube.

The information was submitted for publication at 3 pm CET on October 25, 2024. 

This information was brought to you by Cision http://news.cision.com.

The following files are available for download:

https://mb.cision.com/Public/694/4056931/846c76cc14c009b4_org.png

OX640 Open vial device 1

https://mb.cision.com/Public/694/4056931/870104a5df4c9faa_org.png

Orexo amorphOX technology

https://mb.cision.com/Public/694/4056931/be090a3a4f0e6805_org.png

Nasal Epinephrine Product

Modal title

Also from this source

Orexo announces positive data for powder-based intranasal vaccine formulated with the AmorphOX technology

Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), today announces positive in-vivo proof-of-concept data for a powder-based intranasal vaccine candidate...

Orexo announces positive topline data from clinical study of OX640 in subjects with and without allergic rhinitis

Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), today announces positive topline results from the clinical study OX640-002. The study evaluated the...

More Releases From This Source

Explore

Health Care & Hospitals

Health Care & Hospitals

Medical Pharmaceuticals

Medical Pharmaceuticals

Pharmaceuticals

Pharmaceuticals

Medical Equipment

Medical Equipment

News Releases in Similar Topics

Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT
  • General Enquiries
  • Media Enquiries
  • Partnerships

Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United States
  • Vietnam

My Services

  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
  • Data Privacy

Do not sell or share my personal information:

  • Submit via Privacy@cision.com 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 PR Newswire Europe Limited. All Rights Reserved. A Cision company.