Intec Pharma Launches Phase 1 Trial of Cannabinoid-based Therapy for Fibromyalgia, Lower Back Pain

Intec Pharma Launches Phase 1 Trial of Cannabinoid-based Therapy for Fibromyalgia, Lower Back Pain

Israel’s Intec Pharma has initiated a Phase 1 clinical trial evaluating AP-CBD/THC to treat several disorders including fibromyalgia and lower back pain.

The Jerusalem-based company developed AP-CBD/THC using its Accordion Pill platform containing the two cannabinoids most present in Cannabis sativa – cannabidiol (CBD) and tetrahydrocannabinol (THC). The therapy aims to extend the absorption phase of CBD and THC, resulting in an improved therapeutic effect.

AP-CBD/THC can potentially address certain drawbacks of current cannabinoids, including short effect duration, delayed onset, variable exposure and variable dosage, among other adverse events that correlate with peak levels.

Cannabis sativa is used to treat chronic pain and other indications. Previous studies have shown that plant extracts containing certain amounts of CBD and THC could potentially treat chronic, neuropathic and inflammatory pain conditions that do not respond positively to currently available treatments.

The Phase 1 study is a crossover trial designed to compare the pharmacokinetics, safety and tolerability of two formulations of AP-CBD/THC with Buccal Sativex (an oral spray containing CBD and THC) in 21 randomized healthy volunteers from one site only. Participants will receive a single-dose of the drug. Topline results are expected in the third quarter of this year.

“The progression of AP-CBD/THC into the clinic is a significant achievement for Intec and marks a major step forward in developing a potential new therapy for pain management. It is also our first demonstration of the Accordion Pill platform for cannabinoid therapies.” Zeev Weiss, Intec Pharma’s CEO, said in a press release. “Moving forward, we plan to evaluate the Accordion Pill platform in several other indications where a safe, effective, prolonged and consistent cannabinoid therapy may be able to provide therapeutic benefit where other treatments have failed.”

Cannabis-derived products are gaining medical attention and will likely represents about 10 percent of the specialty pharmaceutical market over the next five years, according to the company.

Fibromyalgia is a chronic musculoskeletal pain disorder that affects 2 to 5 percent of the U.S. population, primarily women. Common symptoms  include chronic widespread pain, nonrestorative sleep, fatigue and morning stiffness.

 

20 comments

  1. Ruth Szymansky says:

    I am currently on cbd oil for my chronic pain . Doesn’t due anything for my IBS that is a comorbity of the fibromyalgia.
    Cbd oil is the only thing legal in North Carolina .
    I am frustrated by what little help is available for the symptoms of fibromyalgia.
    If they had a suit that people could wear for a day to feel the pain more would be done ✅

    • Judy Ohanian says:

      Hi Ruth, I just recently tried a CBD oil and a THC oil combination and found some pain relief for a few hours. FM pain relief is being researched as this article shows and there is hope! I know, it just doesn’t feel it will come fast enough for those who suffer so much on a daily basis. Hang in there, and if you ever have a chance to add a little THC to the CBD it will make a difference.

    • Rachel Sue Josey says:

      I completely agree. I suffer a combination of 3 chronic illnesses and I get so angry at the pain and the inability to get meds for pain. I like the suit idea.

  2. Imogen Martin says:

    I tried straight up “medical marijuana” – an indica strain promoted by our local MMJ Advocate / grower about two years ago. I live in a state that has legalized it, so we can grow and make oil for personal use. It helped me understand the chronic myofascia pain aspect of my fibromyalgia, which led to a chronic Lyme disease diagnosis. I found that high THC strains emphasize fibromyalgia pain, probably because it activates the CNS/ANS. When CBD is used to offset THC, then the results are so much better. However, CBD Hemp Oil alone was almost useless to address fibromyalgia pain. It improved mood and anxiety levels, but did not address nerve pain issues. I learned through trial and error that THC / CBD has to be proportional, and it is best to take it “full entourage;” that is, whole plant medicine and extracts for full benefits. I did not find sativa preferable over indica for pain relief, either. I use a combo of strains to vape or make oil that I constantly adapt to my needs. I do not know how this could be standardized.

    • Cindy Thomas says:

      Dear Imogen, I haven’t heard anything or anyone having myofascial pain associated with fibromyalgia. And the you were later diagnosed with Lyme? So which is causing the myofascial pain? Where is your pain? I have it on the side of my face. It feels like I’ve been hit with a baseball bat!

  3. I have also heard of a CBD patch you can wear, but it is not yet in Oregon where marijuana is legal. I am hoping to try the patch when it becomes available as it slowly releases CBD so that you don’t always have to use the oil (I use the oil and the eatables) and have to continue to use throughout the day. Let’s hope this patch helps a lot. My pain days seem to be getting worse as I grow older. Bummer

  4. Pamela Gustafson says:

    I have Fibromyalgia, IBS, etc. All the pain that comes with it. I also have lower back pain due from a lower back injury. I have recently missed a couple doses of my Gabepentin and experienced night terrors that scared the hell out of my granddaughter. I read some articles regarding people having a terrible time getting off that medication and now I know what they were talking about. I would welcome the opportunity to try the the canabis items being tested in order to get off that terrible night terror medication!!

  5. Sandra foster says:

    Hi I suffer with fibermyagia and would like to try CBS oil but have no idea what is strongest as I have a high tolerance through years of opiates that I am now reducing From I need some advise on what oil to get

    • Julie Parsons says:

      Myofasvial pain is inside under skin.It is a knot that feels prolly and squishy. There are a few doctors that due myofascial injections or pressure points. I have a friend that swears by them. Its not in my town It would have to travel there so “not”

    • Julie Parsons says:

      Myofascial pain is inside under skin.It is a knot that feels rolly and squishy. There are a few doctors that due myofascial injections or pressure points. I have a friend that swears by them. Its not in my town It would have to travel there so “not”

  6. Robert says:

    I am a male who has had fibromyalgia for almost 5 years now. Most if it is not pain but constant ache that feels like I have the flu. All I want to do is lie down and sleep. I tried the cbd oil for a month and it did nothing but cost me a couple hundred dollars.
    I hope a cure comes soon because the meds I take only help a little.
    Best of luck to all of you.
    Robert

  7. Hi Sandra,

    First of all, it is CBD (not CBS TV channel:) oil and CBD is the derivative of the plant that helps with pain without having any THC effects. You want to get the highest CBD you can. My pen cartridge has 38% CBD and 42% THC. It only takes one hit for me to feel the pain relief without getting high and it really helps. I also use Cannabis-infused Belgian chocolates that are 13.1 mg CBD and only 1.5 mg THC. I can pop one of these in my mouth (they are delicious) and not get any effects of the THC. However, I have not found anything that is 100% CBD until I read about the patch. Hence, the reason why I am waiting for this to be available in my state.

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