Cannabinoid Treatment for Pain Linked to Fibromyalgia May Soon Enter Clinical Testing

Cannabinoid Treatment for Pain Linked to Fibromyalgia May Soon Enter Clinical Testing

Initial clinical testing of a cannabinoid-based treatment for fibromyalgia and peripheral neuropathic pain, known as  ZYN001, may soon begin,  Zynerba Pharmaceuticals announced.

Zynerba, a clinical-stage specialty pharmaceutical, is developing next-gen synthetic cannabinoid treatments formulated for transdermal delivery. A transdermal patch is intended to allow sustained and controlled delivery of two the company’s therapeutic cannabinoids: cannabidiol (CBD), a non-psychoactive cannabinoid, and tetrahydrocannabinol (THC).

CBD and THC can act as pain relievers in central nervous system of patients experiencing pain, such as fibromyalgia patients.

ZYN001 is a pro-drug of THC, delivered through a skin-adherent patch, so that it will be absorbed through the skin and go directly into the circulatory system.  This avoids what is known as  first-pass liver metabolism, when the liver breaks down therapeutics taken orally, allowing only a small amount of the drug to be absorbed into the circulatory system. (Pro-drugs are medicines administered in an inactive/less active form, which are then converted and metabolized inside the body.)

Avoiding first-pass liver metabolism, the company reports, could potentially allow for lower dosing.  THC delivered orally can also cause high peak blood levels of THC, potentially increasing psychoactive side effects. According to Zynerba, ZYN001 presents more consistent blood levels with fewer peaks and valleys, suggesting an improved tolerability profile.

A Phase 1 study evaluating the safety, tolerability and pharmacokinetic profile of ZYN001 in healthy volunteers is planned to begin by mid-year. If successful, Zynerba intends to begin two Phase 2 trials later this year in patients with fibromyalgia and peripheral neuropathic pain.

“We enter 2017 with great momentum and expect it to be a transformational year with several key milestones expected in the coming months, including top-line results from the three ZYN002 clinical trials and the commencement of our clinical program for ZYN001, our patent-protected pro-drug of THC in development for the treatment of fibromyalgia and peripheral neuropathic pain,” Armando Anido, chairman and chief executive officer  of Zynerba, said in a press release.

ZYN002, the company’s other lead candidate, is being developed for the treatment of epilepsy, osteoarthritis and Fragile X syndrome, a genetic disorder that causes a range of developmental problems.

15 comments

  1. Amy says:

    How can I be considered as a trial participant? I have both fibromyalgia and peripheral neuropathic pain, mainly in legs but also somewhat in my arms. I am glad this company is moving treatment for our disorder up a notch to try to help us out with pain.

  2. Denise Bault says:

    Although I am very happy to see that a patch is being developed, I can’t for the life of me understand why a “synthetic” has to be produced, when the real thing is already available and has been for thousands of years. Oh yea, so Big Pharma can get their cut! What was I thinking?

  3. June Farrell says:

    How can I find out more about the Clinical Study? I am not finding anything on internet. I have been diagnosed with fibromyalgia for 35 years. I am interested in participating.

  4. Kathy D says:

    I have Fibromyalgia (have had it since 2000), as well as, epilepsy(have had it since 2008). I really would love to be a part of the clinical trials for CBD therapy. Is this company looking for patients? I’m in Ontario, Canada.

  5. Judy Franz says:

    Where is this study taking place? I would love to be a participant! So glad this clinical trial is taking place.

  6. John Quintner says:

    I am highly skeptical of any claims being made that cannabinoids might offer new hope to those with the too easily acquired label of fibromyalgia. Caveat emptor!!!

  7. Andrea says:

    Or, you could bypass the pharmaceutical industry all together and just smoke pot to achieve the same effects. That’s what I do with my medical card.

  8. Danielle says:

    How can I get in on this? I have been on bed rest for a week now. I have a home and family to take care of and can’t do it while laying in bed

  9. Elena Corbin says:

    I would like to participate in the Phase 2 trials for one or both of these drugs. The side effects of the duluxotine and the Lyrica are almost as disabling as the Fibromyalgia itself

  10. Carol Squirrell says:

    Could I be considered as a candidate for this clinical trial. I am a fibro sufferer and in a great deal of pain.l cam travel and don’t have any work or family commitments.

  11. Stephen Ball says:

    I’d love my 85 year old mother to at least try medical canabis. Non of her regular treatment relieves pain. This is not a great way to spend your 80’s in pain. I feel for her every day.

  12. Mar says:

    I am concerned that they are developing “synthetic” cannabis. Totally unnecessary. They can you the real thing, getting a;; parts of the plant to the patient. Not sure how they can copy it and get all the benefits associated with the reall stuff.

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