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.