AXIM Biotechnologies, Inc. (AXIM Biotech) (OTC:AXIM), a world leader in cannabinoid research and development, today announced that it has entered into a Services Agreement with an Israel-based contract research organization (CRO) to begin a clinical proof of concept study (POC) with its cannabidiol (CBD) and Gabapentin chewing gum product to treat restless leg syndrome (RLS) in patients.
The PK and double blind, randomized, single-center phase 2 trial, which will be conducted in Israel by the CRO, will demonstrate the efficacy of AXIM’s chewing gum product composed of Gabapentin and CBD on around 30 study participants to treat RLS.
“We are excited to be able to contract with an Israeli CRO to conduct a pre- and a clinical proof-of-concept study for this unmet medical need condition. Israel is in the forefront of clinical cannabinoid research and we are thankful for having this opportunity. RLS is a prevalent condition affecting between 3.9-14.3% of the US population. The available treatments are not very effective and often cause severe side effects,” said George E. Anastassov, MD, DDS, MBA and Chief Executive Officer of AXIM Biotech. “We hope that our proprietary treatment modality utilizing cannabinoids and gabapentin in functional chewing gum will prove to be effective in alleviating the symptoms of RLS.”
Restless leg syndrome (RLS), also known as Willis–Ekbom Disorder (WED), is a condition associated with nocturnal sensorimotor symptoms, or nocturnal spasms of the muscles of the lower extremities, that can result in significant sleep disruption and severe pain. RLS is a prevalent condition, affecting an estimated 3.9–14.3 % of the US population. RLS can negatively affect a patient’s quality of life (QoL) across several domains, such as daytime sleepiness, decreased general health, decreased immune function, stress and mood.