FDA Asked to Place Cannabis-based Therapy for Progressive MS on Fast Track, MMJ Holdings Says

FDA Asked to Place Cannabis-based Therapy for Progressive MS on Fast Track, MMJ Holdings Says

A request for a potential cannabis-based treatment for multiple sclerosis to be given Fast Track designation, speeding its development as it readies to enter clinical testing, is now before the U.S. Food and Drug Administration (FDA), MMJ International Holdings announced.

MMJ-001, as this lead candidate is known, aims to treat the spasticity (muscle stiffness) associated with progressive multiple sclerosis. The company is also targeting Huntington’s-associated chorea, a neurological disorder characterized by jerky involuntary movements that particularly affect the shoulders, hips, and face.

Specifically, MMJ-001 is a liquid therapeutic formulation made from highly purified components of cannabis, cannabidiol (CBD) and tetrahydrocannabinol (THC), the company states on its website. CBD and THC are the most abundant cannabinoids in the cannabis plant; CBD is non-psychoactive component of the cannabis oil and believed to have neuro-protective properties, while THC is the principal psychoactive constituent of cannabis.

MMJ International is exploring the potential of a range of cannabinoid and other botanical molecules targeting neurological diseases, the company said in a news release.

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It is also planning to bring MMJ-001 into a first “dose-ranging” study — a clinical trial testing different treatment doses to establish which dose works best and is safest and most tolerable, MMJ said in a separate release. In this study, still in the planning stages, researchers will compare therapeutic formulations of THC and CBD to placebo.

The request to place MMJ-001 on a fast track is related to its development as a therapy for primary progressive multiple sclerosis (PPMS). The FDA’s fast track expedites the review and approval of experimental treatments for serious or life-threatening diseases with the potential to fill patients’ unmet medical needs.

“The positive data from this dosing study is important in that it will provide us with the necessary evidence on patient tolerance to different doses of THC and CBD for the treatment for PPMS,” Duane Boise, the company’s CEO, said in the release. “This information will prove valuable to assist clinicians with prescribing decisions to address individual patient needs should this medicine be FDA approved for use.”

MMJ has also requested FDA approval to test its cannabis-based candidate in Huntington’s patients, announcing in August the filing of an Investigational New Drug (IND) application to begin clinical testing. MMJ-002, as its cannabis-based candidate for Huntington’s is known, was recently designed an orphan drug by the FDA and a Phase 2 clinical trial in Huntington’s patients is “scheduled,” the company said in a Feb. 13 release.

MMJ recently became the first company to obtain a Canadian license to produce medical cannabis products aiming to treat multiple sclerosis and Huntington’s disease.

If approved by the FDA, MMJ’s lead therapeutic will be one of the world’s first natural plant-derived cannabinoid pharmaceuticals for the treatment of spasticity and pain caused by multiple sclerosis and other neurological diseases.

22 comments

  1. Deborah Landau says:

    THE MS SOCIETY CAME OUT AND MOCKED THIS THERAPY FOR YEAR. ALL OF A SUDDEN THEY ARE ON THE BAND WAGON? SOMEBODY MUST BE HAVING THEIR POCKETS LINED. HOW MANY KIDS HAVE TO WALK FOR THIS BEFORE YOU WILL HELP THEIR FAMILY MEMBERS? NEVER DID A THING FOR ME IN 32 YEARS. FARCE OF AN ORGANIZATION. THE MONEY GOES TO CORPORATE-NOT PATIENTS.

    • Ms. Nikki Barr says:

      I AGREE! I’ve had MS for 25years, I’ve tried for years.., many, many ways to get this Medicine, the Only herb which helps me and yet I get NO HELP from so-called specialists 😑

    • Ruth says:

      And how much is it going to cost if this will end up being a prescription thru pharmacy. A lot more then buying from medical marijuana store. I was diagnosed in 2002. I did research before deciding the route I wanted to take per my Dr. I came across Low dose Naltrexone 4.5 mg hcl. My doctor went out of his way and called the doctor at mayo clinic that treated his MS pts. My problem at that time was I could barely stay awake. I decided on this route. I called the MS society and asked their opinion. They were totally against it since they never studied it. After one week taking 1 pill at 9pm every night I had so much energy to make it thru the day and then some. I even opened my own business helping senior citizens. My personal doctor now prescribes it to his ms pts and my neurologist also started to prescribe to his pts. Well now ms society is doing research on naltrexone, 15 years later. Sometimes you have to be your own advocate.

  2. Tom mayfield says:

    After being diagnosed with RRMS in ’09 and going through several years of taking drugs (Copaxone for 12 months then Tysabri for approx. 12 months) then tested pos for the JC virus with no positive affect was rediagnosed with PPMS. Currently now on Ocrevus and am questioning how to tell if it is working. Noticed lately that my legs are stiff when trying to get off the bed, so I guess Ocrevus does not address spacticity as I have taken 3 infusions. Anyway if you are looking for anymore patients with PPMS for testing, here I am.

  3. Ronald Hutchison says:

    MMJ001, is a product I feel can help me and improve greatly my quality of life. I’m a disabled veteran with PPMS this article is speaking to my issue how can you help me.

  4. Mary Ann Cincinnati says:

    It’s about time!!! I have PPMS and have severe spasticity 24/7. Meds DON’T help me. All they did was make me even more tired than I already was. I’m so tired of the pharmaceutical companies trying to make a buck and docs throwing them at you and not caring about how MMJ can help. I have a doc like that😡. All she related it to was the opioid addiction problem in this country. It’s bad here in WV. I can guarantee if she or her child had an issue, she’d jump on it.

  5. Mary Ann Cincinnati says:

    I don’t see my post so I’ll try again.

    It’s about time!!! I have PPMS with severe spasticity 24/7. I’ve tried every muscle relaxer w/o success. I’m tired of the pharmaceutical companies trying to make a buck, and docs not educated or caring to be. Doc I have just relates it to the opioid problem in this country. It is bad here in WV. Well, I could just about guarantee that if she or one of her children had a debilitating disease, she would jump on it!

  6. Gary Englerth says:

    I was diagnosed in 1987 , waited seven years before they committed . Had a period of twenty years where life was ok. Then things changed, had exacerbation and was told I had secoundary progressive ms. There were no treatments for me! Fell thru the cracks none of my primary care docs suggested anything! Mayo said I was too far along for any treatments now. So fast forward to present having in limbo seeing a Mayo resident so they can learn to document every six months!

  7. Dorothy Kane says:

    I have SPMS and started having spasms in my right foot and right leg in bed at night. I tried a relatively small dose of Baclofin, which made me very, very sick with nausea and weakness for almost a week. I don’t usually drink alcohol, but had a small glass of celebratory wine one night and had no problem with spasms. I live in California, where weed is legal for medical and recreational use so I tried it (the type is called Indica which is a relaxant). It works even better than the wine. So I usually have wine every night, but if I’m not feeling well and want to go to sleep in a hurry, I have the Indica. Works like a charm.

    • Lidia pacheco says:

      Do you smoke that or is it like cbd oil. I know nothing about that stuff . I have spms and my spasticity is very bad and baclofen doesn’t help
      Thanks,
      Lidia

  8. Cyn Doyle says:

    I have been on med. cannabis for just over a year….it is a miracle drug ! I DO NOT agree with smoking it….mine is in an edible oil. The dose is very small…but really works. It is easily prescribed for MS here , because the doctors know that it works. I have SPMS now and am a senior….two things that make treatment options limited. Medical marijuana is about the only thing left….and it is the best option , in my opinion. As far as opioid use and addiction….marijuana is used to get people OFF of opioids ! Keep trying to get it…it is a great drug when used properly.

  9. I have been diagnosed with MS on 2001, on 2004 they said I have secondary progressive. No tablet help me for spasticity, now I am taking CBD oil, help me but I am looking forward to try Cannabis oil, find out if it is even better.

  10. Greg J. says:

    I’m a former pro golfer and dx’ed ppms in 2010. It scares myself to look back all my lost time and failed therapies.. baclofen, low dose naltraxone, tysebri, high dose biotin, tecfidera. Thank God I found physical therapy and medical marijuana. Spacisity is under control and tolerable and sleep is so much better. I favor vaping the pure oil of indica dominant hybrids. I am wheelchair bound, however I can now use a walker to walk up to 100 yards. PT + MMJ is not a cure but it far exceeds what nmss, doctors and pharma prescribe.

  11. Tamara says:

    Needs to be for all forms of MS. People with MS like me with RRMS need it too. We can’t get into the HSCT trials either. I have to be in the middle of an attack to be accepted for these. So, once again, I’m not sick enough to get the treatments I need! They need to start from scratch with research for MS. MS treatments are based on old science or retrofitted science. They don’t know the cause, but when they diagnose us, they guess and label us in one of 4 kinds of MS based on MRI scans that can’t see the disease. I have lesions in my spine and Cranial nerves that caused pain and dysfunction for years before they could see it on MRI. Which means, by the time they saw a lesion, it was already inactive, so nothing is done. The science is all wrong for diagnosis.

  12. Donald Wright says:

    My girlfriend has ppms,in Wyoming marijuana is ILLEGAL but she smokes it anyways. I hate the smell and it makes her stupid.. how can I tolerate this?

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