With a desperate need for pain management alternatives, a study has shown how an orally absorbed CBD tablet could hold promise.
The tablet – ORAVEXX – has been shown to manage pain after minimally invasive rotator cuff surgery safely.
The study’s findings, carried out by researchers at the Department of Orthopedic Surgery at NYU Langone Health, were presented at the American Academy of Orthopaedic Surgeons (AAOS) 2022 Annual Meeting in Chicago.
Lead investigator Michael J. Alaia, MD, associate professor in the Department of Orthopedic Surgery at NYU Langone Health, commented: “There is an urgent need for viable alternatives for pain management, and our study presents this form of CBD as a promising tool after arthroscopic rotator cuff repair.
“It could be a new, inexpensive approach for delivering pain relief, and without the side effects of anti-inflammatory drugs like NSAIDs and addiction risks linked to opiates. Additionally, CBD has the benefit of pain relief without the psychotropic effects associated with THC or marijuana.”
For the Phase 1/2 clinical trial, 99 participants between the ages of 18 and 75 were randomly sorted across two study sites into a placebo group and a group receiving oral-absorbed CBD. Participants were prescribed a low dose of Percocet, instructed to wean off the narcotic as soon as possible and to take the placebo/CBD three times a day for 14 days after the surgery.
On the first day after surgery, patients receiving CBD experienced, on average, 23 per cent less pain as measured by the Visual Analog Scale (VAS) pain score compared to patients receiving the placebo.
This demonstrated that in patients with moderate pain, CBD may render a significant benefit.
On both the first and second days after surgery, patients receiving CBD reported 22 to 25 per cent greater satisfaction with pain control compared to those receiving placebo. Further analysis also showed that patients receiving 50 mg of CBD reported lower pain and higher satisfaction with pain control compared to patients receiving placebo. No major side effects were reported.
Dr Alaia added: “Our study is examining a well-designed, carefully scrutinised product under an investigational new drug application sanctioned by the FDA. This is currently still experimental medicine and is not yet available for prescription.
NYU Langone Health has launched a second study to determine whether ORAVEXX can specifically treat chronic pain in osteoarthritis patients. Multiple Phase 2 studies are also planned to evaluate the drug’s efficacy for other acute and chronic pain management issues and assess the role of CBD in inflammation.
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