AXIM® Biotechnologies has taken the steps necessary to begin Phase II clinical trials on a cannabinoid-based functional chewing gum for the treatment of restless leg syndrome.
AXIM® Biotechnologies recently entered into a Services Agreement with an Israel-based contract research organization (CRO) to conduct clinical research on their newest CBD-based chewing gum product.
This agreement allows AXIM® to begin a clinical proof of concept study with its CBD and Gabapentin chewing gum product to treat restless leg syndrome (RLS) in patients.
By combining Gabapentin with CBD, the company hopes to decrease RLS symptoms like severe pain, increase sleep quality, and lessen restless sensations in the limbs. Gabapentin is a nerve pain and anti-seizure medication often prescribed for patients with shingles. Gabapentin is already marketed by certain name brand pharmaceuticals for the treatment of RLS. A typical dose of Gabapentin for RLS is 600 mg a day.
The pharmacokinetic and double blind, randomized, single-center Phase II trial, which will be conducted in Israel by the CRO, will demonstrate the efficacy of AXIM’s chewing gum product on 30 study participants. Composed of 300 mg Gabapentin and 60 mg CBD, each piece of AXIM®’s chewing gum cuts 50% off a typical Gabapentin dose for RLS by adding CBD.
RLS, also known as Willis-Ekbom Disease, is a neurologic sensorimotor disorder that is characterized by an overwhelming urge to move the legs when they are at rest. RLS is most impactful at night and can lead to insomnia in some cases. It is estimated that 5 million U.S. adults (about 2 to 3 percent) have moderate to severe RLS.
In most cases, doctors don’t know the cause of RLS in their patients. However, it is suspected that it may be linked to genes since it seems to be shared within families. Other factors could include chronic diseases, medications, alcohol use, sleep deprivation, and even pregnancy.
There is currently no accepted cure for RLS, and treatment focuses on the mitigation of symptoms. Non-drug treatment options include leg massages, increased activity during the day, hot baths, and alternating hot and cold compresses.
AXIM® Biotechnologies is hoping that their combination CBD and Gabapentin functional chewing gum will help to reduce the symptoms of RLS, providing a safe and effective treatment option for the millions of sufferers worldwide.
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