• 🌎 Worldwide
    • πŸ‡ΊπŸ‡Έ U.S.
    • πŸ‡¨πŸ‡¦ Canada
    • πŸ‡¬πŸ‡§ United Kingdom
    • 🌏 Asia
    • 🌍 Europe
    • 🌎 Latin America
    • 🌏 Oceania and Australasia
The Daily Marijuana Observer
SUBSCRIBE
  • Home
  • Latest
  • Business
  • Investments
  • Law
  • People
  • Health
  • Databases
No Result
View All Result
The Daily Marijuana Observer
  • Home
  • Latest
  • Business
  • Investments
  • Law
  • People
  • Health
  • Databases
No Result
View All Result
The Daily Marijuana Observer
No Result
View All Result
Home Health

Tetra Receives its 4th FDA Orphan Drug Designation

Tetra's PPP004 cannabinoid drug receives Orphan Drug Designation for the Treatment of Epidermolysis Bullosa

ACCESSWIRE by ACCESSWIRE
April 16, 2020
in Health, Investments, Marijuana Stocks, Press Releases
Submitting a Comment to the FDA on CBD in Foods and Beverages

Photo Credit - The U.S. Food and Drug Administration via Flickr

101
SHARES
ShareShare

OTTAWA / ACCESSWIRE / April 16, 2020 /Β Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX-V:TBP);(OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, is pleased to announce that it has received U.S. Food and Drug Administration (FDA) Orphan Drug Designation for its cannabinoid PPP004 (THC-CBD) in the treatment of epidermolysis bullosa.

Epidermolysis bullosa is a group of rare diseases that cause fragile, blistering skin and is associated with significant pain and reduced quality of life. Patient management is based on lifestyle changes and home care. If unsuccessful in the control of the signs and symptoms of this disease, further treatment will include medications, surgery and rehabilitation. Epidermolysis bullosa is a condition that commonly progresses despite treatment and can cause serious complications and death.

PP004 will be used for management of pain and itch in EB, symptoms that, despite a range of current treatment strategies, significantly affect the quality of life and activities of daily living among EB patients “Our preclinical research was completed for taking PPP004 into human clinical trials. We have a vast experience in the development of topicals with the recent completion of two clinical trials with AwayeΓ” and expect to rapidly bring this product into trials. In the coming days, we will be reaching out to physicians specialized in the treatment of this disease to discuss a potential proof of concept clinical trial,” commented Dr. Melanie Kelly CSO, Tetra Bio-Pharma Inc.

“We are very pleased to have received this new Orphan Drug Designation (ODD) from the FDA. Orphan designation qualifies PPP004 for development incentives that include tax credits for clinical trials, 7-years of marketing exclusivity and the marketing application (505(b)(1) NDA application) is not subject to prescription drug user fees. These incentives are critically important to a small biopharma,” said Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma. Dr. Chamberland further added, “Tetra will be assessing to launch a proof of concept trial in the coming months and will be requesting a Type B meeting with the US FDA to discuss the marketing requirements for this Orphan Drug indication. The Company will provide an update to share holders once the meeting is confirmed.”

About PPP004

PPP004 is a topical cream containing a 1:1 ratio of synthetic cannabinoids delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD) in strengths of 2%, 1%, and 0.5% w/v. The base product is a proprietary formulation utilizing Active Pharmaceutical Ingredients (APIs) sourced from qualified Good Manufacturing Practices (GMP) adherent manufacturers, and GRAS (generally regarded as safe) excipients from well-known suppliers. The cream will be packaged in a metered-dose, airless pump system, designed to deliver a consistent dose of API per actuation of the pump and to protect the APIs from known sources of degradation, namely light and oxygen.

About Tetra Bio-Pharma

Tetra Bio-Pharma (TSX-V:TBP);(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed and approved, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies. Could we work in “existing regulatory standards of safety and clinical evidence for pharmaceutical products”.

For more information visit:Β www.tetrabiopharma.com

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-looking statements

Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research and development strategies, including the success of this product or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

For further information, please contact Tetra Bio-Pharma Inc.:

CONTACT:

Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433
tetra@alphabronze.net

SOURCE:Β Tetra Bio-Pharma

Share this:

  • Click to email this to a friend (Opens in new window)
  • Click to share on Twitter (Opens in new window)
  • Click to share on Facebook (Opens in new window)
  • Click to share on LinkedIn (Opens in new window)
  • Click to share on Reddit (Opens in new window)
  • Click to share on Telegram (Opens in new window)
  • Click to share on WhatsApp (Opens in new window)
  • Click to share on Pinterest (Opens in new window)
  • Click to share on Tumblr (Opens in new window)
  • Click to share on Pocket (Opens in new window)
Tags: biotechcannabidiolCBDFDAOTC:TBPMFPPP004Tetra Bio-Pharma Inc.tetrahydrocannabinolTHCTSXV:TBPU.S. Food and Drug Administration

Get Real-Time Updates from MJobserver.com

Unsubscribe
ACCESSWIRE

ACCESSWIRE

ACCESSWIRE began as a regional newswire disrupting an industry that had become complacent about engagement, analytics and straightforward pricing. Since then, ACCESSWIRE has become one of the fastest growing global news agencies, with distribution in 98 countries, thousands of customers and a talented, dedicated team.

Related Posts

PLUS Products Announces Date for the Release of Third Quarter 2019 Results, Conference Call and Webcast
Press Releases

Plus Products Partners with CannRx Biosciences to Leverage Proprietary Onset Technology

February 4, 2021
Cannabis Stock News
Investments

YCBD Stock Outpaces Cantor Fitzgerald Analyst Price Target

February 4, 2021
Epidiolex from GW Pharmaceuticals
Investments

Jazz Pharmaceuticals to Acquire GW Pharmaceuticals plc, Creating an Innovative, High-Growth, Global Biopharma Leader

February 3, 2021
CBD Coffee News
Business

The Jordre Well, LLC Submits CBD-Infused Coffee Samples to Labs for Testing

January 21, 2021
CBD Vaping: Why So Many People Have Started
United States

CBD Vaping: Why So Many People Have Started

January 11, 2021
CBD And The Rise Of The Wellness CafΓ©
Lifestyle

CBD And The Rise Of The Wellness CafΓ©

November 16, 2020
Load More
Next Post
Illinois Cannabis News

Cresco Labs Completes Expansion of Illinois’ Largest Cannabis Cultivation Facility in Lincoln

Leave a Comment! Cancel reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

🚨 Subscribe to Stock Alerts

Get Live Updates on Breaking News

Subscribe Now

βœ‰οΈ Subscribe to Our Newsletter!

* indicates required

πŸ”Ž Search Marijuana Stocks

πŸ“° Recent News

  • Verano Holdings Enters into Agreement to Expand Arizona Footprint
  • Green Thumb Industries Announces Initial Public Offering in the U.S. to Raise US$100,000,000
  • Greenlane Announces Dismissal of Remaining Securities Class Action
  • Indiva Reports Record Market Share for January 2021
  • Acreage Announces Fourth Quarter And Full Year 2020 Earnings Date
Facebook Twitter Instagram LinkedIn Youtube

Cannabis News by Region

  • πŸ‡ΊπŸ‡Έ United States
  • πŸ‡¨πŸ‡¦ Canada
  • πŸ‡¬πŸ‡§ United Kingdom
  • 🌏 Asia
  • 🌍 Europe
  • 🌎 Latin America
  • 🌏 Oceania and Australasia

Cannabis Tools & Resources

  • πŸ“… Calendar
  • πŸ“Š Databases
  • πŸ“‡ Directories
  • πŸ”” RSS Feeds
  • πŸ“Ί Videos

Find Cannabis Business Services

  • βš–οΈ Attorneys & Law Firms
  • πŸ“Š Accountants & Accounting Firms
  • πŸ’‘ Consultants & Consulting Firms
  • πŸ“² Marketing Agencies & Firms

The Daily Marijuana Observer

  • Subscribe
  • About MJobserver.com
  • Affiliate Marketing Disclosure
  • Legal Disclaimer
  • Privacy Policy
  • Contact Us

Advertise with Us

  • πŸ‘€ Advertise
  • πŸ“£ DMO Newswire
  • πŸ“‡ List in Our Databases

Β© 2018 - 2021 D.M.O. Holdings Corp.
DISCLAIMER: DMO Holdings Corp., which owns The Daily Marijuana Observerβ„’ (MJobserver.com), is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. DMO Holdings Corp., which owns MJobserver.com, may from time to time have a position in the securities mentioned herein and will increase or decrease such positions without notice. Before making specific investment decisions, readers should seek their own professional advice and that of their own professional financial adviser. DMO Holdings Corp. or its affiliates, which owns MJobserver.com, may be compensated for its services in the form of cash-based and/or equity- based compensation in the companies it writes about, or a combination of the two.

No Result
View All Result
  • Home
  • Latest
  • πŸ”’ PRO
    • πŸ”’ A.M. Watchlist
    • πŸ”’ Analyst Action
  • πŸ’Ό Business
  • πŸ“ˆ Investments
    • πŸ“ˆ Stocks
    • πŸ’° ETFs and Funds
    • πŸ’­ Market Commentary
    • πŸ“° Press Releases
    • πŸ“… Earnings Calendar
  • βš–οΈ Law
    • Laws
    • Politics
    • Intellectual Property
    • Attorneys & Law Firms Database
  • πŸ‘₯ People
    • ⚽ Athletes
    • πŸ’Ό Executives
    • 🌟 Celebrities
    • πŸ›’ Consumers
    • βš•οΈ Doctors
    • πŸ’Š Patients
  • πŸ’Š Health
  • πŸ“‡ Databases
    • πŸ“ˆ Stock Databases
    • πŸ’° Fund Databases
    • πŸ’Ό Service Providers Databases
    • 🏦 Marijuana Stock Brokers
    • πŸ’² Marijuana Cryptocurrencies

Β© 2018 - 2021 D.M.O. Holdings Corp.
DISCLAIMER: DMO Holdings Corp., which owns The Daily Marijuana Observerβ„’ (MJobserver.com), is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. DMO Holdings Corp., which owns MJobserver.com, may from time to time have a position in the securities mentioned herein and will increase or decrease such positions without notice. Before making specific investment decisions, readers should seek their own professional advice and that of their own professional financial adviser. DMO Holdings Corp. or its affiliates, which owns MJobserver.com, may be compensated for its services in the form of cash-based and/or equity- based compensation in the companies it writes about, or a combination of the two.

Login to your account below

Forgotten Password? Sign Up

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In
loading Cancel
Post was not sent - check your email addresses!
Email check failed, please try again
Sorry, your blog cannot share posts by email.