Restless Legs Syndrome keeps over five million Americans up at night.
Soon, they might be able to chew some cannabinoid gum before bed to get a good night’s sleep.
Innovative biotechnology company AXIM® Biotechnologies, Inc. announced they’ll soon start Phase II clinical trials on its newest cannabidiol (CBD)-based chewing gum.
This latest move from AXIM® Biotech comes on the heels of its announcement earlier this summer that the company filed a patent for a chewing gum designed to treat opioid addiction.
Also known as Willis-Ekbom Disorder, Restless Legs Syndrome is a neurological sensorimotor condition characterized by an irresistible urge to move the legs. RLS often leads to significant sleep problems that adversely affect mood, stress levels, immune function, and general health.
There is currently no accepted cure for the condition, treatment efforts typically focus on managing its associated symptoms with drugs, massage, hot baths, physical activity, and alternating hot and cold compresses.
By combining CBD with gabapentin, already an established treatment of RLS, AXIM® Biotech believes its new functional chewing gum will further help patients by lowering severe pain, increasing sleep quality, and reducing the restless sensations of the limbs.
George E. Anastassov, CEO of AXIM® Biotech, said “The available treatments [for RLS] are not very effective and often cause severe side effects. 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.”
By adding CBD, each piece of AXIM® Biotech’s gum cuts a typical 600 mg dose of gabapentin for RLS in half. Gabapentin’s most common side effects include dizziness, drowsiness, weakness, nausea, diarrhea, constipation, blurred vision and headaches.
An Israel-based contract research organization will conduct a pharmacokinetic and double blind, randomized, single-center Phase II clinical trial on the CBD and gabapentin chewing gum per an agreement with AXIM® Biotech. The Phase II trial will involve around 30 participants diagnosed with RLS.