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 Patient Enrolled in Phase 2 Clinical Trial Evaluating JZP150 for Once-Daily Treatment of Adults with Post-Traumatic Stress Disorder

This image opens in the lightbox

News provided by

Jazz Pharmaceuticals plc

30 Dec, 2021, 12:45 GMT

Share this article

Share toX

Share this article

Share toX

U.S. FDA granted JZP150 Fast Track designation in PTSD, underscoring the unmet needs of patients 

If approved, JZP150 would become the first new drug approved in 20 years for patients with PTSD; topline data readout anticipated by the end of 2023

DUBLIN, Dec. 30, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the first patient has been enrolled in a Phase 2 clinical trial evaluating the safety and efficacy of JZP150, an investigational first-in-class small molecule for the treatment of adults with post-traumatic stress disorder (PTSD). JZP150 is a highly selective inhibitor of the enzyme fatty acid amide hydrolase (FAAH), designed to address the underlying cause of PTSD (impairment of fear extinction and its consolidation), as well as patients' associated symptoms (anxiety, insomnia and nightmares).

JZP150 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for PTSD based on the serious nature of the disorder. According to FDA, this designation is intended to facilitate the development and expedite the review of medicines that treat serious conditions and have the potential to address unmet medical needs.

"FDA's Fast Track designation of JZP150 is a notable recognition of both the serious, ongoing, unmet medical needs of PTSD patients and the potential benefits of JZP150's novel mechanism to treat this debilitating disorder," said Rob Iannone, M.D., M.S.C.E., executive vice president, research and development and chief medical officer of Jazz Pharmaceuticals. "The disease burden for PTSD can have a devastating impact on patients and their families for this common condition where the prevalence is expected to increase. Jazz is dedicated to developing and commercializing innovative medicines and progressing the clinical development of JZP150 is the start to a meaningful journey to help people living with PTSD."

PTSD is a psychiatric disorder that affects millions of people and patients frequently have uncontrolled symptoms that impact their ability to perform activities of daily living and function socially.1,2 Currently approved medicines have limited efficacy and no cure is available for the condition.3,4,5 Only two antidepressants have received approval from FDA for the treatment of PTSD symptoms in the past 20 years.6,7,8 No approved therapies target the underlying biology that transforms such traumatic events and experiences into the chronic mental health illness of PTSD.  

"PTSD profoundly affects the lives, relationships and careers of people living with the disorder. We need better treatments to help those that are traumatized reclaim their lives," said John H. Krystal, M.D., Robert L. McNeil Jr., professor of translational research and professor of psychiatry, neuroscience, and psychology at Yale University. "JZP150 targets a novel mechanism in the brain, and this new Phase 2 trial in PTSD will help us to learn more about the molecule's safety and effectiveness as a potential treatment for patients who would benefit from a novel therapy."

About the Phase 2 Trial
The multicenter, double-blind, randomized, placebo-controlled clinical trial will evaluate two doses of JZP150, and is being conducted across 40 U.S. study sites. The trial will enroll 270 adults aged 18 to 70 diagnosed with PTSD using the criteria of the American Psychiatric Association's Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5).9

The primary endpoint of the trial measures participants' changes from the study start to the end of treatment using a score from the Clinician-Administered PTSD Scale (CAPS-5). CAPS-5 is structured clinical interview and is considered the gold standard for diagnosing and assessing patients with PTSD. It includes 30 items with which physicians can make PTSD diagnoses and evaluate the severity of the symptoms as well as the impact on social and occupational functioning.11 The trial has several secondary endpoints, including changes in scores on the Clinical Global Impressions Severity and the Patient Global Impression of severity scales from study start to the end of treatment.              

About JZP150
JZP150 is an investigational small molecule formulated to selectively inhibit the enzyme fatty acid amide hydrolase (FAAH) and is currently in development for the treatment of post-traumatic stress disorder (PTSD) in adults. In PTSD, fear extinction deficits contribute to the persistence of traumatic memories.12 Interventions to promote fear extinction learning are the foundation of PTSD treatment.12 Current first-line pharmacological treatments, such as selective serotonin reuptake inhibitors, mitigate some symptoms of PTSD, but are not designed to address the core underlying problem (fear extinction learning and its consolidation).12 Data from previous preclinical and clinical studies with JZP150 provide evidence that FAAH inhibition can improve the recall of fear extinction memories and attenuate the anxiogenic effects of stress.13,14,15,16,17 

Jazz acquired worldwide rights to JZP150, formerly called PF-04457845, from SpringWorks Therapeutics in October 2020. Pfizer Inc. originally discovered and developed the molecule and exclusively licensed it to SpringWorks.18

About Post-Traumatic Stress Disorder
Post-traumatic stress disorder (PTSD) is a common psychiatric condition that can result from direct or indirect exposure to traumatic events and experiences.3 Individuals with PTSD have intense and disturbing thoughts and feelings related to their experience that persist long after their traumatic event, and they may relive the event through flashbacks or nightmares and feel sadness, fear, anger, and detachment from other people.19 The burden of PTSD is immense with patients struggling to control their symptoms, perform daily activities and function socially.1,2 There is a significant unmet need for patients with PTSD as there is no therapy that treats the root cause of the disorder.

About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases—often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. Within these therapeutic areas, we are identifying new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharma.com and follow @JazzPharma on Twitter.

Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the significance of JZP150's Fast Track designation; the potential timing of the availability and potential benefits of JZP150 for people with post-traumatic stress disorder and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current plans, objectives, estimates, expectations, and intentions 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: pharmaceutical product development; the regulatory approval process; effectively commercializing any product candidates; and other risks and uncertainties affecting the company and its development programs, including those described 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 Jazz Pharmaceuticals' Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 and future filings and reports by Jazz Pharmaceuticals. Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect Jazz Pharmaceuticals' forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise. Jazz Pharmaceuticals undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

Media Contact:
Kristin Bhavnani
Head of Global Corporate Communications
Jazz Pharmaceuticals plc
CorporateAffairsMediaInfo@jazzpharma.com
Ireland +353 1 697 2141
U.S. +1 215 867 4948

Investors:
Andrea N. Flynn, Ph.D.
Vice President, Head, Investor Relations
Jazz Pharmaceuticals plc
investorinfo@jazzpharma.com
Ireland +353 1 634 3211
U.S. +1 650 496 2717                                                

References:

  1. Kessler RC, Aguilar-Gaxiola S, Alonso J, et al. Trauma and PTSD in the WHO world mental health surveys. European Journal of Psychotraumatology. 2017;8(sup5):1353383.
  2. Watson P. PTSD as a public mental health priority. Current Psychiatry Reports. 2019;21(7):1-2.
  3. American Psychiatric Association (APA). Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Publishing; 2013.
  4. Goldstein RB, Smith SM, Chou SP, et al. The epidemiology of DSM-5 posttraumatic stress disorder in the United States: results from the National Epidemiologic Survey on Alcohol and Related Conditions-III. Soc Psychiatry Psychiatr Epidemiol. 2016;51(8):1137-1148. doi:10.1007/s00127-016-1208-5.
  5. Burri A, Maercker A. Differences in prevalence rates of PTSD in various European countries explained by war exposure, other trauma and cultural value orientation. BMC Res Notes. 2014;7:407. Published 2014 Jun 28. doi:10.1186/1756-0500-7-407.
  6. Ehret M. Treatment of posttraumatic stress disorder: Focus on pharmacotherapy. Ment Health Clin. 2019;9(6):373-382. Published 2019 Nov 27. doi:10.9740/mhc.2019.11.373
  7. Zoloft® (sertraline hydrochloride) tablets, for oral use. US Prescribing Information. Roerig, New York, NY, US. December 2016.
  8. Paxil® CR (paroxetine) extended-release tablets, for oral use. US Prescribing Information. GlaxoSmithKline, Research Triangle Park, NC, US. September 2019.
  9. American Psychiatric Association (APA). Diagnostic and Statistical Manual for Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Publishing; 2013.
  10. Weathers FW, Litz BT, Keane TM, Palmieri PA, Marx BP, Schnurr PP. The PTSD Checklist for DSM-5 (PCL-5). 2013. Scale available from the National Center for PTSD at www.ptsd.va.gov. Accessed December 29, 2021.
  11. Weathers FW, Blake DD, Schnurr PP, Kaloupek DG, Marx BP, Keane TM. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). [Assessment] 2013. Available from www.ptsd.va.gov.
  12. Mayo LM, Rabinak CA, Hill MA, et al. Targeting the endocannabinoid system in the treatment of posttraumatic stress disorder: a promising case of preclinical-clinical translation. Biological Psychiatry. 2021
  13. Kathuria S, Gaetani S, Fegley D, et al. Modulation of anxiety through blockade of anandamide hydrolysis. Nat Med. 2003;9(1):76-81.
  14. Patel S and Hillard CJ. Pharmacological evaluation of cannabinoid receptor ligands in a mouse model of anxiety: further evidence for an anxiolytic role for endogenous cannabinoid signaling. Journal of Pharmacology and Experimental Therapeutics. 2006;318(1):304-11.
  15. Mayo LM, Asratian A, Lindé J, et al. Elevated anandamide, enhanced recall of fear extinction, and attenuated stress responses following inhibition of fatty acid amide hydrolase: a randomized, controlled experimental medicine trial. Biological Psychiatry. 2020;87(6):538-47.
  16. D'Souza DC, Cortes-Briones J, Creatura G, et al. Efficacy and safety of a fatty acid amide hydrolase inhibitor (PF-04457845) in the treatment of cannabis withdrawal and dependence in men: a double-blind, placebo-controlled, parallel group, phase 2a single-site randomised controlled trial. The Lancet Psychiatry. 2019;6(1):35-45.
  17. Mayo LM, Asratian A, Lindé J, et al. Protective effects of elevated anandamide on stress and fear-related behaviors: translational evidence from humans and mice. Mol Psychiatry. 2020;25(5):993-1005. doi:10.1038/s41380-018-0215-1
  18. Jazz Pharmaceuticals. Jazz Pharmaceuticals Acquires SpringWorks Therapeutics' FAAH Inhibitor Program. October 26, 2020. http://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-acquires-springworks-therapeutics-faah 
  19. American Psychological Association. Post-traumatic Stress Disorder. https://www.apa.org/topics/ptsd. Accessed December 29, 2021.

Logo - https://mma.prnewswire.com/media/272253/Jazz_Pharmaceuticals_Logo.jpg

Related Links

http://www.jazzpharmaceuticals.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

Pharmaceuticals

Pharmaceuticals

Medical Pharmaceuticals

Medical Pharmaceuticals

Health Care & Hospitals

Health Care & Hospitals

Mental Health

Mental Health

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.