MMJ Enters Agreement to Produce Cannabis-based Capsules for Clinical Trials in MS and Huntington’s
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MMJ International Holdings announced that it has entered into an agreement for the production of its proprietary cannabis-based gel capsule — a product mix of tetrahydrocannabinol (THC) and cannabidiol (CBD) — in compliance with guidelines set by the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA).
The agreement, made with a pharma solutions company, aims to allow MMJ to launch clinical trials of its oral capsule as a possible treatment for multiple sclerosis (MS) and Huntington’s disease (HD).
THC and CBD are two of the most abundant cannabinoids found in the cannabis plant. CBD is a non-psychoactive component of cannabis and believed to have neuroprotective properties, while THC is the main psychoactive constituent of cannabis.
“We firmly believe that our MMJ natural whole plant derived molecules with a unique combination of pharmacological properties will be FDA approved as a safe and effective prescription drug that can be of great benefit in treating patients with MS and HD diseases,” Duane Boise, CEO of MMJ International Holdings, said in a press release.
Planned clinical trials are expected to provide the data necessary to demonstrate that cannabis-based products help patients to manage the tremors and motor control issues common to several neurological disorders.
Several academic institutions are now preparing trials testing the safety and efficacy of daily treatment with MMJ’s gelatin capsules in people with MS and Huntington’s, Boise said.
“As MMJ International Holdings continues to advance to its clinical trials, a specialty pharmaceutical solutions company will be supporting MMJ with the FDA, DEA,” said Elio Mariani, PhD, executive vice president of research and development. “Patients will benefit from cGMP [current Good Manufacturing Practice]-quality therapies in an accessible and efficient format.”
Its release did not identify the pharma solutions company that will handle manufacturing of the gel capsules.
MMJ-001 and MMJ-002 are among the company’s lead therapeutic candidates. MMJ-001 is being developed to treat spasticity (muscle stiffness) in MS, and MMJ-002 to treat Huntington’s-associated chorea, or uncontrolled and involuntary movement.
MMJ-002 was designated an orphan drug by the FDA in January as a potential Huntington’s treatment. Like MMJ-001, it is a liquid formulation of highly purified CBD/THC.
The FDA sent warning letters to several companies selling cannabis-based products containing CBD in October, MMJ notes in its release, alleging they made unsubstantiated claims about the health benefits of their products’ benefits to patients “without sufficient evidence or FDA approval.”
The agency is working “to further clarify the regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies,” Amy Abernethy, MD, PhD, FDA’s principal deputy commissioner, said in one warning noted by MMJ.
“We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products,” Abernethy aded. “We are committed to advancing our regulation of these products through an approach that … prioritizes public health, fosters innovation and promotes consumer confidence.”
Mary ellen azack
How do sign up for trials?
I've had ms 2 long. 55 now.
Call me to Guinea pig .
.
30 years since diagnosis. 55
Mary Clemson
22 years
Mary Clemson
22 secince age 26
Melba Green
I want to sign up. I take 3 different meds for muscle spasms and stiffness
Mary Clemson
I was also taking pain pills but they did not help at all
Mary Clemson
Would like to try capsols to take away my pain
Laura
Sign me up please 15 yrs I have shared my life with MS on2 different muscle relaxants antivert (dizzy) cymbalta (depression) APS made its appearance in January blood clots in legs. The joint pain some days are worse than child birth. I need help.
Ashley Russell
I would love to be apart of the trial too. It would help tremendously with my spasticity among other symptoms. Where do we sign up?
Teresa Padgett
I would love to be a part of this trial.
Currently taking Bacoflen for MS spasticity.
Mark R
19 years...been blind 6 weeks, rapid advancement the past two years, Tec only does so much for me...I take 2 stomach pills, Vitamins D3 5000iu, B Complex 2500iu, Dr Mercola Protein Shake every morning mixed with my multivitamin powder, an ibuprofen as needed. Every day...so I am a medical grower now for 5 years. Along with other licensed friends that share MS, PD and Fibromyalga, we have learned how to make personal use oil, butter, etc. Since using the tincture oil, I have been able to feel relaxed with no psych feelings. Completely functional with little pain, less shaking, less muscle spasms or not as severe. I am definitely proof that benefits exist.
Kristina Shures
I would like to participate in this trial. I haven’t found the right meds for many of my MS symptoms.
Gail
I am in year 16 and just started adding CBD and THC products (state authorized dispensaries only) two months ago to my daily med list. I am seeing some results in the pain level of my numb foot/shin and would welcome the opportunity!! ??
Sheila Gunter
Sign me up!
Had MS for 29 yrs.
I’m now on the last medication I can take. Due to other med, I now am jcv positive.
I’ve been Praying this would get here sooner than later.
??
Denise Gallaro
Please notify when clinical trials are available. I am asking for my 34 yr old daughter who has MS and raising a child on her own who has autism.
Rob T.
Lemme tell all those who have commented here, IT DOES HELP TREMENDOUSLY, and WILL HELP ALL OF YOU TOO!! I myself am another example of undeniable TRUTH and FACT that it does in fact work. I woke up blind in Sept. 2012, FINALLY TRIED smoking about 2014 to stop the shaking and tremors. The VERY FIRST TIME I hit it, the shaking STOPPED!! COMPLETELY!! Needless to say, I haven't shook since then, and don't plan on shaking ANYMORE. I began my MS journey in 2012, taking a TOTAL of "29 PILLS" daily. When I chose to add Marijuana to my regimen, well, I'll just say I swallow 4 to 7 pills a day now, simply on an AS NEEDED BASIS. It really wasn't that difficult of a decision for me to make. Swallow HANDFULS of "MAN-MADE CHEMICALS" into my body, or incorporate 1 NATURALLY GROWN "HERB" into my body?? Duh! Natural vs. Man-made? I'm not sure about you all, but my choice is going "NATURAL", especially when it has to do with putting substances into my body. My only problem, is I live in "ALABAMA", so it's a TAKE WHATEVER YOU CAN GET sort of deal. Then there's the issue of it being COMPLETELY ILLEGAL in Alabama, which could really send me up "SCHITT'S CREEK"! Me and my wife have discussed the whole "WHAT IF" scenario, and both have concluded that the BENEFITS OUTWEIGH THE RISKS, so I'm forced to fly under the radar, and hopefully can stay there until something's done legislatively within the state government to FINALLY, at a MINIMUM, approve it for MEDICAL PURPOSES..
Marina Moore
I would like to sign up for this trial. I am a 68 year old female with PPMS. I don't know the correct formula of the THC & CBD to use & am very interested in learning more. I've tried some here & there with little to no success as I'm not sure of the amounts used. Too much THC & I don't do well.
How do you sign up?
Sandra Hickey
I would love to participate - currently on several meds for muscle spasms. Sometimes they work - sometimes they don't... Please put my name on the "very interested" list!!!
Jane Munn
I am interested in being part of this study. I am 56 & have primary progressive MS. I currently use both but it would be nice to try a regulated form of the product. Currently I am seeing such a difference from vender to vender.
Lashanda
I would like to participate in this trail. Have had MS for 16 years.