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CBD Tablet Shown to Reduce Post-Operative Pain

Hands covering face

(Victoria Borodinova, Pixabay.

25 Mar. 2022. Findings from a clinical trial show a rapidly disintegrating cannabidiol tablet reduces pain with few adverse effects in patients having shoulder surgery. Results of the trial conducted at medical centers in New York and Jacksonville, Florida are scheduled for presentation today at a meeting of the American Academy of Orthopaedic Surgeons in Chicago.

Health authorities continue to search for non-opioid alternatives for treating acute pain, such as from trauma or surgery. Opioid drugs are still prescribed for acute pain in many cases, which can lead to dependence or abuse. In the U.S., abuse of opioid pain drugs continues at rates reaching emergency levels, along with heroin and fentanyl sold on the street. Last month, Science & Enterprise reported on new Food and Drug Administration regulatory guidance for review of non-opioid treatments for acute pain.

The clinical study tested a pain treatment made from cannabidiol or CBD, a compound derived from the Cannabis sativa plant, but does not produce an emotional high associated with marijuana, also a derivative of cannabis. National Library of Medicine in the U.S. says some 80 chemicals, known as cannabinoids, are associated with these plants. One of those chemicals, CBD, a non-intoxicating derivative, makes up about 40 percent of cannabis extracts and has been studied extensively for a range of disorders.

The pain treatment in this case is Oravexx, developed Orcosa Inc. in Ewing, New Jersey. Oravexx contains a CBD compound formulated into a tablet designed to quickly disintegrate while in the mouth. As the tablet disintegrates, says Orcosa, its active ingredients are absorbed by tissue in the cheek in about three seconds. People taking Oravexx or other medications using this technology do not need to drink water or swallow a pill.

Less severe pain after one day

The early-stage clinical trial enrolled 99 adult patients receiving arthroscopic rotator cuff repair, a common injury of shoulder muscles, particularly among athletes. All participants first received a low dose of the opioid pain-killer Percocet immediately after surgery, as well as instructions to wean themselves from the drug as quickly as possible. Participants then received Oravexx in 25 or 50 milligram doses or an oral-disintegrating placebo, taken three times a day for 14 days.

The study team, led by NYU orthopedic surgery professor Michael Alaia, looked primarily at participants’ responses to a standard visual scale of pain experience, as well as reports of nausea, both for 14 days. Participants also reported any other use of opioids or CBD over that time, as well as satisfaction with their treatment.

Results show patients receiving Oravexx rate their pain as 23 percent less severe than placebo recipients, one day after surgery. Oravexx recipients also report 22 to 25 percent greater satisfaction with their treatment than placebo recipients in the first two days following surgery. In addition, Oravexx recipients in 50 milligram doses report less pain and more satisfaction with their treatment than the 25 milligram dose recipients. And researchers say Oravexx participants report no major adverse effects.

“There is an urgent need for viable alternatives for pain management,” says Alaia in an NYU Health statement, “and our study presents this form of CBD as a promising tool after arthroscopic rotator cuff repair.” Alaia adds, “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.”

In an Orcosa statement, company founder and CEO Mark Ridall says the clinical trial, “lays the foundation for several upcoming phase 2 (mid-stage) studies in the treatment of acute and chronic pain utilizing Oravexx.”

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