• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Nutraceuticals
    • Markets
    • Health
    • Jobs
    • Events
    • Buyers' Guide
    • Showcases
    • More
  • Magazine
  • News
  • Exclusives
  • Nutraceuticals
  • Markets
  • Health
  • Jobs
  • Events
  • Buyers' Guide
  • Showcases
  • Current & Past Issues
    Features
    Columns
    Editorials
    Digital Edition
    Subscribe Now
    Advertise Now
    eNewsletter
    Editorial Guidelines
    Top Features
    Health Products Association - China Executive Director Reflects on Market Dynamics, Challenges

    Blood Sugar Management: Personalized Testing Drives Home The Need for Early Intervention

    New and Evolving Formulation Options Must Be Mindful of Blood Sugar Maintenance

    Tapping Functional Beverages to Meet Modern Wellness Needs

    Adaptogens: Where Ancient Remedies Meet Modern Wellness Products
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Japanese Mushroom Extract Appears Helpful in HPV Infections

    Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected

    United Plant Savers Launches First Film Festival

    Azelis Opens Food and Nutrition Lab in Cairo, Egypt

    Florida Food Products Acquires Javo
    Exclusives
    Blogs & Guest Articles
    Health E-Insights
    Area Code 420
    eBook
    Antioxidants
    Dairy-Based Ingredients
    Enzymes
    Fatty Acids
    Fiber & Carbohydrates
    Green Foods
    Herbs & Botanicals
    Marine Nutraceuticals
    Minerals
    Omega 3s
    Probiotics & Prebiotics
    Proteins, Peptides, Amino Acids
    Sweeteners
    Vitamins

    Japanese Mushroom Extract Appears Helpful in HPV Infections

    United Plant Savers Launches First Film Festival

    Roquette Launches Nutralys Rice Protein

    Upcycled Coffeeberry® Cascara Offers Versatility in Functional Beverage Development

    Study Reveals Low Intake of Tocotrienols in Polish Population
    Consumer Trends
    Contract Manufacturing
    Cosmeceuticals / Nutricosmetics
    Delivery & Dosage Technologies
    Dietary Supplements
    Flavors & Colors
    Functional Foods & Beverages
    Healthcare Trends
    Medical Nutrition
    Mergers & Acquisitions
    Natural/Organic
    Nutrition Bars
    Packaging
    Pet Nutraceuticals
    Quality & Safety
    Regulations
    Research
    Testing
    World Markets

    Japanese Mushroom Extract Appears Helpful in HPV Infections

    Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected

    Azelis Opens Food and Nutrition Lab in Cairo, Egypt

    Florida Food Products Acquires Javo

    Roquette Launches Nutralys Rice Protein
    Bone & Joint Health
    Cancer Risk
    Cardiovascular Health
    Cognitive Function
    Diabetes & Blood Sugar Management
    Digestive Health
    Energy
    Eye Health
    Healthy Aging
    Immune Function
    Infant & Children's Health
    Inflammation
    Men's Health
    Mood Health & Sleep
    Oral Health
    Sexual & Reproductive Health
    Skin Health
    Sports Nutrition
    Weight Management/Weight Loss
    Women's Health

    Japanese Mushroom Extract Appears Helpful in HPV Infections

    Upcycled Coffeeberry® Cascara Offers Versatility in Functional Beverage Development

    Botanical Gum for Kids Aims to Curb Sugar Cravings

    Combination of Collagen and Boswellia Serrata Shown to Reduce Joint Discomfort

    Childhood Fitness and Obesity Impact Cognition Later in Life, Study Finds
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Sabinsa Corporation

    JRS Pharma

    ESHA Research

    Nutrition21, LLC

    Xsto Solutions
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    Sabinsa Corporation

    JRS Pharma

    ESHA Research

    Nutrition21, LLC

    Xsto Solutions
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
    • Breaking News
    • Buyers' Guide
      • All Companies
      • Categories
      • Trade Associations
      • Company Capabilities
    • Nutraceuticals
      • Antioxidants
      • Dairy-Based Ingredients
      • Enzymes
      • Fatty Acids
      • Fiber & Carbohydrates
      • Green Foods
      • Herbs & Botanicals
      • Marine Nutraceuticals
      • Minerals
      • Omega 3s
      • Probiotics & Prebiotics
      • Proteins, Peptides, Amino Acids
      • Sweeteners
      • Vitamins
    • Markets
      • Consumer Trends
      • Contract Manufacturing
      • Cosmeceuticals / Nutricosmetics
      • Delivery & Dosage Technologies
      • Dietary Supplements
      • Flavors & Colors
      • Functional Foods & Beverages
      • Healthcare Trends
      • Medical Nutrition
      • Mergers & Acquisitions
      • Natural/Organic
      • Nutrition Bars
      • Packaging
      • Pet Nutraceuticals
      • Quality & Safety
      • Regulations
      • Research
      • Testing
      • World Markets
    • Health
      • Bone & Joint Health
      • Cancer Risk
      • Cardiovascular Health
      • Cognitive Function
      • Diabetes & Blood Sugar Management
      • Digestive Health
      • Energy
      • Eye Health
      • Healthy Aging
      • Immune Function
      • Infant & Children's Health
      • Inflammation
      • Men's Health
      • Mood Health & Sleep
      • Oral Health
      • Sexual & Reproductive Health
      • Skin Health
      • Sports Nutrition
      • Weight Management/Weight Loss
      • Women's Health
    • Online Exclusives
    • Webinars
    • Slideshows
    • Blogs & Guest Articles
    • Health E-Insights
    • Videos
    • Podcasts
    • Infographics
    • eBook
    • Whitepapers
    • Research
      • TrendSense
      • Monograph Center
      • White Papers
      • Research News
    • Jobs
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Supplier Showcases
      • Companies
      • Product Releases
      • News Releases
      • Literature / Brochures
      • White Papers
      • Jobs
      • VIdeos
      • Services
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA Approves First Drug with Active Ingredient Derived from Marijuana

    Agency prepared to take action against ‘illegal marketing of CBD-containing products with serious, unproven medical claims.'

    FDA Approves First Drug with Active Ingredient Derived from Marijuana
    Related CONTENT
    • Sunflower Hemp Co
    • FDA Rejection of NDINs for Full Spectrum Hemp Extracts Fails to See Key Differences from Drugs
    • Confusion Over Cannabis & The Fate of CBD
    • FDA Expands List of Ingredients Approved as Dietary Fiber
    • Petition Seeks Health Claim for Vitamin D, Lower Risk of Preterm Birth
    06.25.18
    The U.S. Food and Drug Administration has approved Epidiolex (cannabidiol) [CBD] oral solution to GW Research Ltd. for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.
     
    CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). It is THC (and not CBD) that is the primary psychoactive component of marijuana.
     
    “This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, MD. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”
     
    Dravet syndrome is a rare genetic condition that appears during the first year of life with frequent fever-related seizures (febrile seizures). Later, other types of seizures typically arise, including myoclonic seizures (involuntary muscle spasms). Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others.
     
    Lennox-Gastaut syndrome begins in childhood. It is characterized by multiple types of seizures. People with Lennox-Gastaut syndrome begin having frequent seizures in early childhood, usually between ages 3 and 5. More than three-quarters of affected individuals have tonic seizures, which cause the muscles to contract uncontrollably. Almost all children with Lennox-Gastaut syndrome develop learning problems and intellectual disability. Many also have delayed development of motor skills such as sitting and crawling. Most people with Lennox-Gastaut syndrome require help with usual activities of daily living.
     
    “The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said Billy Dunn, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”
     
    Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex, taken along with other medications, was shown to be effective in reducing the frequency of seizures when compared with placebo.
     
    The most common side effects that occurred in Epidiolex-treated patients in the clinical trials were: sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor quality sleep; and infections.
     
    Epidiolex must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. As is true for all drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression and panic attacks. Epidiolex also caused liver injury, generally mild, but raising the possibility of rare, but more severe injury. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice and/or dark urine.
     
    Under the Controlled Substances Act (CSA), CBD is currently a Schedule I substance because it is a chemical component of the cannabis plant. In support of this application, the company conducted nonclinical and clinical studies to assess the abuse potential of CBD.
     
    The FDA prepares and transmits, through the U.S. Department of Health and Human Services, a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the CSA. DEA is required to make a scheduling determination.
     
    The FDA granted Priority Review designation for this application. Fast-Track designation was granted for Dravet syndrome. Orphan Drug designation was granted for both the Dravet syndrome and Lennox-Gastaut syndrome indications.
    Related Searches
    • Enzymes
    • Children
    • Research
    • Testing
    Related Knowledge Center
    • Herbs & Botanicals
    • Regulations
    Suggested For You
    Sunflower Hemp Co Sunflower Hemp Co
    FDA Rejection of NDINs for Full Spectrum Hemp Extracts Fails to See Key Differences from Drugs FDA Rejection of NDINs for Full Spectrum Hemp Extracts Fails to See Key Differences from Drugs
    Confusion Over Cannabis & The Fate of CBD Confusion Over Cannabis & The Fate of CBD
    FDA Expands List of Ingredients Approved as Dietary Fiber FDA Expands List of Ingredients Approved as Dietary Fiber
    Petition Seeks Health Claim for Vitamin D, Lower Risk of Preterm Birth Petition Seeks Health Claim for Vitamin D, Lower Risk of Preterm Birth
    Taking Aim at the Global Heart Health Crisis Taking Aim at the Global Heart Health Crisis
    FDA Warns Against Products Claiming to Replace Sunscreen FDA Warns Against Products Claiming to Replace Sunscreen
    FDA Extends Nutrition Facts Label Compliance Dates FDA Extends Nutrition Facts Label Compliance Dates
    FDA Cracks Down on Highly Concentrated Caffeine in Dietary Supplements FDA Cracks Down on Highly Concentrated Caffeine in Dietary Supplements
    New York Dietary Supplement Manufacturer Ordered to Stop Selling Products New York Dietary Supplement Manufacturer Ordered to Stop Selling Products
    Raphael Mechoulam Receives ABC Norman R. Farnsworth Excellence in Botanical Research Award Raphael Mechoulam Receives ABC Norman R. Farnsworth Excellence in Botanical Research Award
    FDA Releases Guidance on Dietary Fiber and Added Sugars FDA Releases Guidance on Dietary Fiber and Added Sugars
    Solid Dosage Outsourcing Trends Solid Dosage Outsourcing Trends

    Related Buyers Guide Companies

    • Sunflower Hemp Co

      ...
      Colby Terip, Owner 09.15.21

    • Herbs & Botanicals | Quality & Safety | Regulations
      FDA Rejection of NDINs for Full Spectrum Hemp Extracts Fails to See Key Differences from Drugs

      FDA Rejection of NDINs for Full Spectrum Hemp Extracts Fails to See Key Differences from Drugs

      Multicomponent hemp extracts with trace levels of THC and other naturally occurring compounds have not been approved in any new drug.
      By Todd Harrison, Venable 09.09.21

    • Dietary Supplements | Herbs & Botanicals | Medical Nutrition | Regulations
      Confusion Over Cannabis & The Fate of CBD

      Confusion Over Cannabis & The Fate of CBD

      Fair and reasonable or not, FDA could very well be a major buzzkill in the CBD supplement sector.
      By Erik Goldman, Holistic Primary Care 07.02.18


    • Breaking News | Fiber & Carbohydrates | Industry & Market News | Quality & Safety | Regulations | Regulatory News
      FDA Expands List of Ingredients Approved as Dietary Fiber

      FDA Expands List of Ingredients Approved as Dietary Fiber

      Eight new fibers are now approved for inclusion on the Nutrition Facts label.
      06.19.18

    • Infant & Children's Health | Regulations | Vitamins | Women's Health
      Petition Seeks Health Claim for Vitamin D, Lower Risk of Preterm Birth

      Petition Seeks Health Claim for Vitamin D, Lower Risk of Preterm Birth

      Supplements are affordable, safe, and effective for modifying maternal serum vitamin D levels to improve pregnancy outcomes.
      By Todd Harrison & Michelle Jackson, Venable 06.01.18

    Loading, Please Wait..
    Trending
    • Three Grams Of Omega-3s May Be Optimal Dose For Reducing Blood Pressure
    • 3 grams of Omega-3s May be Optimal Dose for Reducing Blood Pressu
    • Olive/Pomegranate Extract May Improve Dyslipidemia
    Breaking News
    • Japanese Mushroom Extract Appears Helpful in HPV Infections
    • Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected
    • United Plant Savers Launches First Film Festival
    • Azelis Opens Food and Nutrition Lab in Cairo, Egypt
    • Florida Food Products Acquires Javo
    View Breaking News >
    CURRENT ISSUE

    June 2022

    • Tapping Functional Beverages to Meet Modern Wellness Needs
    • Adaptogens: Where Ancient Remedies Meet Modern Wellness Products
    • New and Evolving Formulation Options Must Be Mindful of Blood Sugar Maintenance
    • Health Products Association - China Executive Director Reflects on Market Dynamics, Challenges
    • Blood Sugar Management: Personalized Testing Drives Home The Need for Early Intervention
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Japanese Mushroom Extract Appears Helpful in HPV Infections
    Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected
    United Plant Savers Launches First Film Festival
    Coatings World

    Latest Breaking News From Coatings World

    H.M. Royal Becomes Exclusive OCSiAl Distributor
    American Colors to Expand Sandusky, Ohio Facility
    Vaughn O’Dea Named Director of Epoxytec
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Siemens' Varian Gains FDA IDE Nod for FAST-02 Trial
    Acutus Medical Launches AcQCross Line Extension
    Accelmed Partners II, Lauxera Capital Partners Invest in Veranex
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Ixaka & Minaris Sign Tech Transfer & GMP Manufacturing Agreement for Cell Therapy Candidate
    Pfizer, BioNTech Adapt COVID Vax Against Omicron
    CoreRx Expands Capabilities
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Top 5 Beauty Tech Trends at Perfect Corp.'s Global Forum
    John Frieda Supports the LGBTQIA+ Community
    Athena Club Launches in Canada
    Happi

    Latest Breaking News From Happi

    Past Henkel Exec Christian Chopra Named President of Scotch Porter
    Color Street Celebrates Foster, Adoption Awareness with Limited-Edition Print
    CIR Panel Conducts 161st Meeting Regarding Safety Assessments for Cosmetic Ingredients
    Ink World

    Latest Breaking News From Ink World

    Dr. Tammo Boinowitz to Join Management Board of ALTANA AG
    Flint Offset Packaging Solutions Announces Price Increases for Sheetfed Inks
    Weekly Recap: INX’s VC Fund, Screen Industry and Ball Top This Week’s News
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Harveer Sahni recognized with Global Achievement Award
    Color-Logic partners with Taktiful 
    ALTANA announces Management Board change
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Fibertex Personal Care Awarded EcoVadis Awards for Sustainability
    Yanpai Orders Batt Forming Equipment for Needlepunch Line
    Weekly Recap: SWM and Neenah Introduce Mativ Inc., Avgol honored for Biotransformation Technology & More
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Researchers Discover Novel Patching Material for Bone Defects
    Boston Centerless Opens Second Manufacturing Plant in Indiana
    Researchers Develop Patient-Specific 3D-Printed Smart Metamaterial Implants
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Identiv-Powered CVS Spoken Rx Wins NFC Forum 2022 Innovation Award
    LG Display Announces Winners of This Year’s OLEDs GO! Competition
    Weekly Recap: eMagin, Applied Materials, and Schott Top This Week’s Stories

    Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login