AXIM Biotechnologies Inc, which does cannabinoid research and development, has entered into an agreement with an Israel-based contract research organization to begin a clinical proof-of-concept study with its cannabidiol (CBD) and gabapentin chewing gum product to treat restless leg syndrome (RLS) in patients.
The pharmacokinetic and doubleblind, randomized, single-center phase 2 trial, which will be conducted in Israel by the contract research organization, will test 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 [contract research organization] 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,” says George E. Anastassov, MD, DDS, MBA, CEO of AXIM Biotech, in a release. “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 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.