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
  • Multichannel Amplification
  • 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
  • Multichannel Amplification
  • 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

Jazz Pharmaceuticals Announces First Patients Enrolled in Phase 3 Clinical Development Program Evaluating JZP-110 as a Potential Treatment of Excessive Daytime Sleepiness (EDS) Associated with Narcolepsy or with Obstructive Sleep Apnea (OSA)


News provided by

Jazz Pharmaceuticals plc

08 Jun, 2015, 13:05 GMT

Share this article

Share toX

Share this article

Share toX

-- Jazz Advances its Clinical Development Program in Sleep and Narcolepsy

DUBLIN, June 8, 2015 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced today that the first patients have been enrolled in a Phase 3 clinical development program evaluating the safety and efficacy of its investigational drug candidate, JZP-110, as a wake-promoting agent in the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy or with obstructive sleep apnea (OSA).  The JZP-110 clinical development program includes three Phase 3 studies being conducted in the United States (U.S.), Canada and the European Union (EU).  The program also includes an open-label extension study to evaluate the long-term safety of JZP-110.

"This R&D milestone represents another step forward in Jazz's development program for JZP-110 and in our efforts to develop new treatment options for people with narcolepsy and with other sleep disorders," said Karen Smith, M.D., Ph.D., Global Head of Research and Development and Chief Medical Officer of Jazz Pharmaceuticals.  "We are excited to advance JZP-110 into Phase 3 clinical development to further evaluate it as a wake-promoting agent, and we look forward to continued collaboration with the FDA and key thought leaders as we advance development of JZP-110."

Clinical Program Study Design

Approximately 880 patients in the aggregate are expected to be enrolled in the three Phase 3 studies to be conducted across 67 medical centers in the U.S., Canada and EU.  The co-primary endpoints for all three Phase 3 clinical studies -- the Maintenance of Wakefulness Test (MWT) and the Epworth Sleepiness Scale (ESS) -- will measure patients' improvement in ability to stay awake and in sleepiness.  Up to 450 patients are expected to be enrolled in the open-label, long-term safety extension study.  For more information on the clinical trials, go to www.clinicaltrials.gov

  • Study 14-002: A 12-week, double-blind, randomized, placebo-controlled, multi-center, four-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of EDS in adult patients with narcolepsy.
  • Study 14-003: A 12-week double-blind, placebo-controlled, randomized, multi-center study of the safety and efficacy of JZP-110 in the treatment of EDS in adult patients with OSA.
  • Study 14-004: A six-week, double-blind, placebo-controlled, randomized-withdrawal, multi-center study of the safety and efficacy of JZP-110 in the treatment of EDS in adult patients with OSA.
  • Study 14-005: A long-term (52 week) open-label safety and maintenance of efficacy study of JZP-110 in the treatment of EDS in adult patients with narcolepsy or with OSA to assess the long-term safety and maintenance of efficacy in patients.

"People living with EDS associated with narcolepsy and patients with unresolved EDS in OSA often experience an inadequate response to, or have difficulty tolerating, their currently prescribed wake-promoting treatment, underscoring the need for new treatment options.  The Phase 3 clinical development program will further define the clinical profile of JZP-110 as a potential alternative for these patients," said Richard Bogan, M.D., Associate Clinical Professor at the University of South Carolina School of Medicine and Chief Medical Officer of SleepMed Inc.  

About JZP-110

JZP-110 is a late-stage investigational wake-promoting agent being developed as a treatment for EDS in adult patients with narcolepsy or with OSA.  Jazz has worldwide development, manufacturing, and commercialization rights to JZP-110, excluding certain jurisdictions in Asia.  The proof of concept for moving into the Phase 3 clinical development program was based on consistent results from two Phase 2 clinical studies evaluating JZP-110 as a potential new treatment of EDS in adult patients with narcolepsy.  The data from the Phase 2b study was previously presented at a late breaker session during the 28th Annual Meeting of the Associated Professional Sleep Societies (APSS) on June 2, 2014.

About EDS

EDS is a primary symptom for patients with narcolepsy and is common in patients with OSA.  Despite current therapies, many patients with narcolepsy or with OSA continue to experience EDS.1, 2  Narcolepsy is a chronic, debilitating, condition that impacts approximately 160,000 people in the United States.3  Less than half of the estimated 160,000 people living with narcolepsy in the U.S. have been properly diagnosed and approximately 50,000 of those who are diagnosed receive wake-promoting therapies.  OSA is a serious chronic sleep disorder in which breathing repeatedly stops and starts during sleep.  In the U.S., approximately 500,000 patients receive wake-promoting therapies for EDS associated with OSA.4   

About Jazz Pharmaceuticals plc

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs.  The company has a diverse portfolio of products and/or product candidates with a focus in the areas of sleep and hematology/oncology.  In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution and Erwinaze® (asparaginase Erwinia chrysanthemi) in the U.S., and markets Erwinase® and Defitelio® (defibrotide) in Europe and other countries outside the U.S. For more information, please visit www.jazzpharmaceuticals.com.  

"Safe Harbor" Statement Under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to Jazz Pharmaceuticals' clinical development program involving JZP-110, the potential of JZP-110 as a wake-promoting agent and to treat EDS associated with narcolepsy or with OSA, Jazz Pharmaceuticals' ability to deliver new treatment options to patients, and other statements that are not historical facts.  These forward-looking statements are based on Jazz Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the difficulty and uncertainty of pharmaceutical product development, the uncertainty of clinical success, such as the risk that results from early clinical trials may not be predictive of results obtained in later and larger clinical trials, the uncertainty of regulatory approval, and those other risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the Quarterly Report on Form 10-Q for the quarter ended March 31, 2015 and future filings and reports by the company.  Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in its expectations.

References:

  1. NA Antic et al. The effect of CPAP in normalizing daytime sleepiness, quality of life, and neurocognitive function in patients with moderate to severe OSA. Sleep. 2011: Jan 1; 34(1):111-9.
  2. C Guilleminault et al. Problems associated with switch to modafinil – a novel alerting agent in narcolepsy. Eur J Neurol.  2000 Jul; 7(4):381-4.
  3. CR Baumann et al. Narcolepsy: Pathophysiology, Diagnosis, and Treatment.  Springer: NY 2011.
  4. SH Launois et al. Current Opinion in Pulmonary Medicine. 19(6):601-608, November 2013.

Related Links

http://www.jazzpharma.com

Modal title

Also from this source

Jazz Pharmaceuticals to Participate in Upcoming June Investor Conferences

Jazz Pharmaceuticals to Participate in Upcoming June Investor Conferences

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that Company management will participate in the following investor conferences: Jefferies...

Jazz Pharmaceuticals Announces First Quarter 2025 Financial Results and Updates 2025 Financial Guidance

Jazz Pharmaceuticals Announces First Quarter 2025 Financial Results and Updates 2025 Financial Guidance

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the first quarter of 2025 and updated financial guidance for 2025. "In...

More Releases From This Source

Explore

Health Care & Hospitals

Health Care & Hospitals

Pharmaceuticals

Pharmaceuticals

Medical Pharmaceuticals

Medical Pharmaceuticals

Clinical Trials & Medical Discoveries

Clinical Trials & Medical Discoveries

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
  • Accessibility Statement
  • 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.