Cannabis Extract Provides ‘Superior Pain Relief’ Compared to Opioids

By Pat Anson

A German pharmaceutical company has released the results of two late-stage clinical trials, showing that a cannabis extract called VER-01 significantly reduces chronic lower back pain. The full spectrum extract, derived from cannabis sativa, provided better pain relief to patients in a head-to-head comparison with low doses of opioids.

Vertanical hopes to get regulatory approval of VER-01 in Europe and with UK regulators in 2026. If granted, VER-01 would be the first cannabis-based medicine approved for use in treating chronic pain. Another study of VER-01 is planned in the U.S. next year, which would be a step towards getting FDA approval.

Findings from the two Phase 3 studies were published separately in the journals Nature Medicine and Pain & Therapy.

“These findings provide powerful evidence that VER-01 could in the future transform how we care for patients with chronic lower back pain,” co-author Charles Argoff, MD, Professor of Neurology at Albany Medical College and past president of the American Academy of Pain Medicine, said in a press release.

“The results of the Phase 3 studies bring hope to millions living with chronic pain that VER-01, once approved, may provide effective pain relief without the risks and harms associated with existing therapies.”

Chronic lower back pain (CLBP) affects more than half a billion people worldwide and is the leading cause of disability. Current treatment options for CLBP are typically limited to physical therapy and non-steroidal anti-inflammatory drugs (NSAIDs), which often don’t work.

In the Phase 3 study, 820 patients with CLBP were given either a placebo or VER-01 over 12 weeks. Those who received the extract had an average pain reduction of 1.9 points on a zero-to-ten pain scale. After six months, pain intensity decreased by 2.9 points, which was sustained over 12 months. Participants also reported improvements in neuropathic pain, sleep quality and physical function.

The other Phase 3 study involved 384 patients with CLBP, who received either VER-01 or opioids for six months. Opioid doses started with a mean daily average of nearly 27 morphine milligram equivalents (MME) and were titrated up to an average of nearly 32 MME, a dosage range that would be considered low or moderate. Opioid options included tramadol, oxycodone, hydromorphone, morphine, and transdermal fentanyl or buprenorphine.

VER-01 was more effective in relieving pain than opioids, especially for patients with severe pain. The average pain reduction with VER-01 was 2.5 points on the pain scale, compared to 2.16 points with opioids. Patients taking VER-01 also had better sleep quality and were less likely to be constipated.

VER-01 was generally well tolerated in both studies, with no evidence of dependence or withdrawal. Side effects such as dizziness and nausea were mild and short-term. Although it contains THC, the main psychoactive substance in cannabis, patients did not become “high” or intoxicated. Each dose of VER-01 contained 2.5 mg of THC, as well as cannabinoids, terpenes and other bioactive compounds that were administered twice daily.

“This study provides robust evidence that VER-01 offers better tolerability, as well as superior pain relief and sleep quality compared to opioids in patients with CLBP. These findings highlight its potential as a promising new pharmacological option within a multimodal treatment approach that could fundamentally shift the paradigm in the treatment of chronic pain,” researchers concluded.

It approved, VER-01 would be sold under the brand name Exilby and be taken orally in drops. Vertanical is also studying VER-01 as a pain treatment for patients with osteoarthritis and peripheral neuropathy.

Research into the pain-relieving properties of cannabis has been slow in the U.S., in large part because of marijuana’s status as an illegal Schedule 1 controlled substance. Although the DEA allows more cannabis to be used for research purposes, the agency has dragged its feet about reclassifying marijuana as a Schedule 3 substance that could be used for medical purposes. Until marijuana is rescheduled, VER-01 is unlikely to get FDA approval. 

WHO Releases First Guideline for Chronic Low Back Pain

By Pat Anson, PNN Editor

The World Health Organization (WHO) has released its first-ever guideline for managing chronic low back pain, recommending treatments such as exercise, physical therapy, chiropractic care and non-steroidal anti-inflammatory drugs (NSAIDs).

Chronic low back pain — also known as “non-specific low back pain” — is defined as pain that persists longer than three months, with symptoms that cannot be accounted for by a structural spinal problem or disease process such as arthritis.

Although lower back pain (LBP) is the leading cause of disability worldwide – affecting about 619 million people – there has been little certainty about how to treat it. Almost all of the clinical trial evidence reviewed by WHO’s guideline development group was considered low or very low quality, a persistent problem.in many medical guidelines dealing with pain.

The lengthy 274-page guideline takes a dim view of some commonly used therapies for LBP, such as muscle relaxants, anticonvulsants, steroids, opioids, transcutaneous electrical nerve stimulation (TENS), and injectable anesthetics – treatments that are primarily used in high-income countries. WHO recommends a more holistic approach to LBP, using therapies that are affordable and accessible to more people.

"Addressing chronic low back pain requires an integrated, person-centred approach. This means considering each person's unique situation and the factors that might influence their pain experience," Dr. Anshu Banerjee, WHO Director for Maternal, Newborn, Child, Adolescent Health and Ageing, said in a press release. "We are using this guideline as a tool to support a holistic approach to chronic low back pain care and to improve the quality, safety and availability of care."

WHO recommends that adults with chronic LBP start with treatments that are the least invasive and least potentially harmful. The values and preferences of patients should also be considered, as they are more likely to adhere to therapies they consider helpful.  

Recommended Treatments for Chronic LBP

• Patient education and counseling

• Exercise or physical therapy

• Acupuncture or dry needling

• Spinal manipulation (chiropractic care)

• Massage

• Cognitive behavioral therapy or mindfulness

• NSAIDs

• Topical cayenne pepper

The guideline states that opioid analgesics “should never be used as a stand-alone treatment” for chronic LBP. When opioids are used alongside other therapies, the lowest dose should be prescribed and only for a short duration, according to WHO.

Recommendations against routine use are also made about many other pharmaceuticals, including antidepressants, anticonvulsants, muscle relaxers, glucocorticoids (steroids), weight loss drugs, and injectable anesthetics such as lidocaine or bupivacaine.  

No recommendations are made about benzodiazepines, cannabis or acetaminophen (paracetamol), primarily due to lack of evidence, but also because of potentially harmful side effects. Cayenne pepper is the only herbal remedy recommended by WHO.

The guideline does not address surgical procedures such as spinal fusions and spinal cord stimulators, or invasive procedures such as epidural injections.

WHO’s 25-member guideline development group included a broad range of clinical experts from around the world. Among them is Roger Chou, MD, a researcher and longtime critic of opioid prescribing who heads the Pacific Northwest Evidence-based Practice Center. Chou is a co-author of the 2016 and 2022 CDC opioid guidelines, and has collaborated on several occasions with members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid advocacy group. Chou let his Oregon medical license lapse in 2022.

One of the clinical trials reviewed by WHO’s guideline group is a controversial Australian study – known as the OPAL study -- that found low dose opioids gave little relief to patients with short-term back and neck pain. The OPAL study has been panned by critics because the treatment period only lasted six weeks and used a formulation of oxycodone that would not normally be used in clinical practice. Nevertheless, it’s been cited as evidence that “prolonged opioid use” is ineffective.

In 2021, WHO updated its guideline on the treatment of chronic pain in children, recommending that prescription opioids only be used for children who are dying or seriously ill. An earlier WHO guideline that recommended more pediatric use of opioids was withdrawn in 2019, after two U.S. congressmen accused the United Nation’s health agency of being “corruptly influenced” by opioid manufactures.