• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Therapix Filed for FDA Orphan designation on Tourette's treatment

Therapix Filed for FDA Orphan designation on Tourette's treatment

June 20, 2016
CenterWatch Staff

Therapix Biosciences, the pharma company specializing in the development and commercialization of cannabinoid-based drugs, announced that it filed an application with the FDA to approve an orphan drug designation for a drug (THX-RS01) developed based on the entourage technology, which combines cannabinoid substances in treating Tourette syndrome.

The application was filed after the completion of the pre-clinical phase and proof-of-concept of the entourage technology and further to the Company's preparations towards the development of a drug based on the technology in the context of clinical trials in humans.

The Orphan Drug Act of 1983 was promulgated to set forth the rights of patients suffering from rare medical conditions, and for such purpose, determined several incentives to encourage pharmaceutical companies to invest in research and development in such fields. The Act defines an "orphan drug" as a chemical or biological agent, used in treating rare diseases that affect less than 200,000 patients in the U.S. Among the incentives provided by the Act are a seven-year market exclusivity commencing on the drug's date of approval; tax benefits; participation in development costs; assistance in regulatory proceedings fast-track registrations; and a full exemption from the FDA's drug registration fees.

The entourage technology is based on the combination of cannabinoid substances or cannabinoid analogs with existing drugs. The technology enables improving the treatment of various medical indications by reducing the standard dosages of the drug, while increasing its efficacy and improving its safety profile.

Dr. Elran Haber, TherapixBiosciences' CEO, said, "The filing of the application for an orphan drug designation is an additional step towards the fulfillment of the Company's business and clinical objectives. The orphan designation route, if approved, will enable an accelerated regulatory process that will shorten time-to-market and facilitate the drug's market accessibility. The Company is simultaneously acting to initiate clinical trials that will begin in H2/2016, subject to receipt of the required approvals, including FDA approval for the commencement of trials in THX-TS."

Several days ago, the company announced the joining of internationally renowned experts, from Israel and the world, to the scientific board and the company's team of consultants, including  James Leckman, a child psychiatrist, psychiatrist and physician at Yale University;  Kirsten Müller-Vahl, Professor of Psychiatry at the Department of Psychiatry, Socialpsychiatry and Psychotherapy of the Hannover Medical School, Germany;  Michael Davidson, Professor of Psychiatry and Chairman of the Stuckinski Centre for Alzheimer's Disease Research in Ramat Gan;  Avi Weizman, Professor of Psychiatry at Tel Aviv University and Director of the Center and Head of Geha Mental Health Center's Research Unit; and Dr. Michael Bloch, a Yale University School of Medicine graduate.

The new experts will join Prof. Raphael Mechoulam, who identified the active compound in cannabis, THC, on the advisory board, and Dr. Yafit Stark, a vice president at Teva serving on the company's board of directors.

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • SurveywBlueBackground-360x240.png

    Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

  • TrendsInsights2023-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Two

  • TimeMoneyEffort-360x240.png

    Time is Money and So Is Effort, Budgeting Experts Say

  • TrendsInsights2023A-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Three

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing