An unnamed Israel-based CRO has been contracted by Axim to conduct clinical trials on two different cannabis chewing gum products.
A contract research organization, or CRO, is an organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis.
The details of the contract are limited as we bring you this breaking story. What we do know is that the Israeli company will be performing a Ph II clinical trial for Axim’s cannabidiol (CBD) and Gabapentin chewing gum products. The trial is set to proceed on a double blind basis, will be randomized, and single-center.
Axim wants to demonstrate the efficacy of their Gabapentin/CBD chewing gum product in approximately 30 study participants to treat restless leg syndrome (RLS). Gabapentin is also known as Neurontin, and is an FDA-approved medication used to treat epilepsy, neuropathic pain, hot flashes, and restless leg syndrome.
Axim CEO George Anastassov told reporters, “We are working now on the protocol of the preclinical trial and AXIM is working in parallel to finalize the formulation.”
For now, Axim’s flagship products include CanChew, a CBD-based controlled release chewing gum, CanChew+, which is undergoing clinical trials in patients with IBS, and MedChew Rx, a combination CBD/THC gum also in clinical trials.
[Featured image credit- The Fresh Toast]