MMJ International Asks FDA to Approve Studies of Cannabis-based Therapies

MMJ International Asks FDA to Approve Studies of Cannabis-based Therapies

MMJ International has filed two applications with the U.S. Food and Drug Administration (FDA) requesting permission to begin clinical studies testing its pharmaceutical grade cannabis-based therapies in easing symptoms associated with multiple sclerosis and Huntington’s disease.

“The filing of these applications with the FDA brings us one step closer to helping persons suffering from these debilitating diseases. As a company, we are committed to researching and developing cannabis based medicines which will improve the lives of people around the world,” Duane Boise, CEO at MMJ International, said in a press release.

The company also has requested a meeting with FDA officials to discuss the development process for  an investigational new drug (IND). A pre-IND meeting with the FDA can help in creating a strategy for the drug development process by reviewing the clinical trial design, sharing ideas, and understanding the specific expectations and requirements for an IND application in the future.

“The MMJ team expects many advantages by requesting a pre-IND meeting,” Boise said.

If approved, the company will be conducting its first-ever clinical trial, testing the effectiveness of natural botanical cannabis extracts as a treatment option for MS and Huntington’s disease, both neurodegenerative disorders.

Previous studies have shown that cannabidiol (CBD), the non-psychoactive component of marijuana, can alleviate spasticity in MS patients. Based on such findings, MMJ anticipates positive outcomes from its trial and is hopeful it will provide new evidence to support the drug development process.

“Our unique scientific approach sets us apart from others in the industry, and we are working hard to create new and innovative pathways geared towards helping doctors treat and [alleviate] the suffering of patients,“ Boise said, acknowledging his team of scientists and industry experts worldwide who have helped develop the company’s portfolio in plant-derived cannabinoid formulations.

In June 2018, MMJ Bioscience, a subsidiary of MMJ International, also applied for a Phase 2 study to evaluate tetrahydrocannabinol (THC)/CBD compounds to ease symptoms in MS patients. MMJ Bioscience is the first company to obtain a license from Health Canada to grow medical marijuana in Canada, and extract cannabinoids from the plant to use in FDA-approved clinical trials.

Vijaya Iyer is a freelance science writer for BioNews Services. She has contributed content to their several disease-specific websites, including cystic fibrosis, multiple sclerosis, muscular dystrophy, among others. She holds a PhD in Microbiology from Kansas State University, where her research focused on molecular biology, bacterial interactions, metabolism, and animal models to study bacterial infections. Following the completion of her PhD, Dr. Iyer went on to complete three postdoctoral fellowships at Kansas State University, University of Miami and Temple University. She joined BioNews Services to utilize her scientific background and writing skills to help patients and caregivers remain abreast with important scientific breakthroughs.
follow me
×
Vijaya Iyer is a freelance science writer for BioNews Services. She has contributed content to their several disease-specific websites, including cystic fibrosis, multiple sclerosis, muscular dystrophy, among others. She holds a PhD in Microbiology from Kansas State University, where her research focused on molecular biology, bacterial interactions, metabolism, and animal models to study bacterial infections. Following the completion of her PhD, Dr. Iyer went on to complete three postdoctoral fellowships at Kansas State University, University of Miami and Temple University. She joined BioNews Services to utilize her scientific background and writing skills to help patients and caregivers remain abreast with important scientific breakthroughs.
follow me
Latest Posts
  • economic burden
  • SAR442168 rrms
  • Aubagio, MS
  • FDA warning

8 comments

  1. Martin Matko says:

    MANY Feel and KNOW So Called Multiple Sclerosis (MS) is a Vascular Mechanical Issue NO Drug Treatment or Cannabis can Solely Rectify! #CCSVI

    • Jason Parris says:

      What is your point, Martin? Is it that MS is less serious than people are experiencing, or that cannabis is not good to research in regard to “so called” MS symptomology?

  2. Kathy Brown says:

    I have had MS, for 15 years. Would like to see if I qualify for clinical trials. Currently use a vapor of marijuana to help with this Monster disease, MS. In horrific pain 24/7. Thank You.

  3. Pansy says:

    I have been living with MS for 20 years and there isn’t a day that I don’t suffer from pain, I hope they look at this as a honest health issue that would be benefiting a lot of people that suffer from this debilitating disease and help us!! Thanks

  4. Ed says:

    The FDA will never approve a cannabis product.
    Look up the history and current status of U S patent # 6630507 and then you will know why.
    This is also why cannabis is still classified as a Schedule 1 drug.

Leave a Comment

Your email address will not be published. Required fields are marked *

Pin It on Pinterest

Share This