• 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
    Supporting Musculoskeletal Health: Tending to Muscles, Joints, and Bones

    2023 Contract Manufacturing Survey

    Dosage and Delivery Innovations Help Manufacturers Meet Common Challenges

    A Paradigm Shift for Antioxidants?

    Manufacturing Dietary Supplements in Economic Uncertainty
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Glossary
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Jones Healthcare Group Primed to Help Nutraceutical Brands Comply with New Packaging Rules

    Nordic Naturals Debuts Probiotic Line in More Than 375 Sprouts Farmer’s Markets

    DolCas Biotech's Curcugen Featured in Beauty-From-Within Supplement

    NOW Tests Bromelain Supplements Purchased on Amazon

    House Reps Try Again to Regulate CBD and Other Hemp Derivatives as Dietary Ingredients
    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

    Nordic Naturals Debuts Probiotic Line in More Than 375 Sprouts Farmer’s Markets

    DolCas Biotech's Curcugen Featured in Beauty-From-Within Supplement

    NOW Tests Bromelain Supplements Purchased on Amazon

    Podcast: Erin Stokes, ND, on Natural Health Strategies and the Role for Dietary Supplements

    House Reps Try Again to Regulate CBD and Other Hemp Derivatives as Dietary Ingredients
    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

    Jones Healthcare Group Primed to Help Nutraceutical Brands Comply with New Packaging Rules

    Nordic Naturals Debuts Probiotic Line in More Than 375 Sprouts Farmer’s Markets

    DolCas Biotech's Curcugen Featured in Beauty-From-Within Supplement

    NOW Tests Bromelain Supplements Purchased on Amazon

    Podcast: Erin Stokes, ND, on Natural Health Strategies and the Role for Dietary Supplements
    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

    Nordic Naturals Debuts Probiotic Line in More Than 375 Sprouts Farmer’s Markets

    DolCas Biotech's Curcugen Featured in Beauty-From-Within Supplement

    NOW Tests Bromelain Supplements Purchased on Amazon

    Podcast: Erin Stokes, ND, on Natural Health Strategies and the Role for Dietary Supplements

    'What’s Up With Supps' Event at Expo West Raises Over $8,000 for Vitamin Angels
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    KLK OLEO

    BGG Americas, Inc.

    Nutrition21, LLC

    Gencor

    Aiya America, Inc. (Aiya Matcha)
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    KLK OLEO

    BGG Americas, Inc.

    Nutrition21, LLC

    Gencor

    Aiya America, Inc. (Aiya Matcha)
    • 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
    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
    • Fatigue
    • Research
    • Children
    • Depression
    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
    • Shiitake Mushroom Extract Appears Helpful In HPV Infections
    • The Functional Chocolate Company Launches Painfree Chocolate
    • Amazon Bans Dietary Supplements Containing NMN
    • Vitamin D Remains Top Supplement Among Users, Popularity Of Probiotics On The Rise: ConsumerLab
    Breaking News
    • Jones Healthcare Group Primed to Help Nutraceutical Brands Comply with New Packaging Rules
    • Nordic Naturals Debuts Probiotic Line in More Than 375 Sprouts Farmer’s Markets
    • DolCas Biotech's Curcugen Featured in Beauty-From-Within Supplement
    • NOW Tests Bromelain Supplements Purchased on Amazon
    • House Reps Try Again to Regulate CBD and Other Hemp Derivatives as Dietary Ingredients
    View Breaking News >
    CURRENT ISSUE

    March 2023

    • Supporting Musculoskeletal Health: Tending to Muscles, Joints, and Bones
    • Dosage and Delivery Innovations Help Manufacturers Meet Common Challenges
    • 2023 Contract Manufacturing Survey
    • Manufacturing Dietary Supplements in Economic Uncertainty
    • Beyond Antioxidants: The Power of Berries
    • A Paradigm Shift for Antioxidants?
    • Ayana Bio on Path to Scale Bioactives Derived from Plant Cell Cultures
    • Nuritas: Leveraging Artificial Intelligence to Speak the Language of Life
    • Dietary Supplement Quality Assurance Programs Critical to Natural Products Industry Success
    • Innovation in Nutraceuticals: Dose Forms and Application Science Help Meet Consumer Demand
    • 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

    Jones Healthcare Group Primed to Help Nutraceutical Brands Comply with New Packaging Rules
    Nordic Naturals Debuts Probiotic Line in More Than 375 Sprouts Farmer’s Markets
    DolCas Biotech's Curcugen Featured in Beauty-From-Within Supplement
    Coatings World

    Latest Breaking News From Coatings World

    Evonik Obtains Certification for VISIOMER Terra Biobased Methacrylates
    Norwegian Cruise Line Goes Biocide-Free with Nippon Paint Marine's AQUATERRAS
    ChemQuest Names Carla McBain a Director
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    SurgVision's EXPLORER AIR II Gets FDA OK
    Brainomix's Flagship Stroke AI Imaging Software OK'ed
    Cue Health Nabs EUA for Molecular Mpox Test
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Infinity Laboratories Names Hank Nowak Commercial Ops SVP
    TC BioPharm Restructures, Cuts Workforce up to 30%
    NImmune Biopharma Launches with Phase 3-Ready Clinical Candidate Omilancor
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    LVMH Appoints Giulio Bergamaschi as CEO of Acqua di Parma
    Consumers ‘Trade Up’ for Prestige Beauty Products Despite Inflation
    Free the Birds Revamps Sunday Riley’s In-Store Retail Experience
    Happi

    Latest Breaking News From Happi

    Barentz Welcomes Bryan Daniels as New Market Acceleration Group Director
    DSM Launches Parsol DHHB UVA Filter for SPF Protection
    Pest Control Brand Zevo Adds Body Sprays and Lotion for Mosquitos and Ticks
    Ink World

    Latest Breaking News From Ink World

    WestRock Holds Ground-Breaking on New Corrugated Box Plant in Washington
    MNYPIA Names John Hrdlick 2023 Anthony Mauriello Award Honoree
    Amcor’s Sustainability Commitment Receives ‘AA’ Rating by MSCI
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    HP debuts HP Indigo 200K digital press
    Meyers announces new Function47 division
    Jones Healthcare invests in Gallus Labelmaster from Heidelberg
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Kimberly-Clark Ranks Third Among 100 Most Sustainable Companies
    Weekly Recap: TerraCycle Launches Diaper Program, Ahlstrom to Divest or Shutter Stenay Plant & More
    Mativ Names CFO
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Loci Orthopaedics Earns New Patent for Thumb Base Joint Implant System
    Study: Running Does Not Increase Arthritis Risk
    Study Highlights the Positive Clinical Outcomes of Medacta’s MySpine System
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Retrofittable Electrochromic Films for Windows and Glass Facades
    Tekscan Launches New High-Speed Tire Pressure Testing System
    Schreiner PrinTrust Produces RFID-Enabled Labels for seventhings

    Copyright © 2023 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