New Cannabis-Based Therapy Shows Promise for Chronic Back Pain
Table of Contents
- 1. New Cannabis-Based Therapy Shows Promise for Chronic Back Pain
- 2. Breakthrough results in Phase 3 Trials
- 3. Superiority Over Opioids and Placebo
- 4. addressing a global Health Crisis
- 5. Understanding VER-01 and the “Entourage Effect”
- 6. Frequently asked Questions About VER-01
- 7. What are the potential long-term effects of VER-01 on patients with chronic low back pain?
- 8. VER-01: A Potential Game-Changer in Chronic Low Back Pain Management – Phase 3 Trial Results
- 9. Understanding the Opioid Crisis and the Need for Alternatives
- 10. VER-01: How Does it Work?
- 11. Phase 3 Trial Results: A Detailed Look
- 12. Benefits of VER-01 Over Traditional Opioids
- 13. Patient Selection and Eligibility Criteria
- 14. Real-World implications and Future Directions
- 15. Practical Tips for Managing Chronic Low Back Pain (While Awaiting VER-01 Availability)
Groundbreaking clinical trial results suggest a novel cannabinoid-based medicine,
VER-01, could revolutionize the treatment of chronic low back pain, offering
a potential alternative to opioids and conventional pain management
strategies.
Breakthrough results in Phase 3 Trials
The biopharmaceutical company VERTANICAL has unveiled positive findings from
two Phase 3 clinical studies evaluating VER-01, a full-spectrum Cannabis
Sativa extract, for chronic low back pain (CLBP). These studies, published
in Nature Medicine and Pain & Therapy, were also presented
at the German Pain Congress.
According to findings,VER-01 not onyl offered considerably better pain
relief compared to a placebo but also showcased improved tolerability
relative to opioid-based treatments. Importantly, the trials revealed no
evidence of dependence or abuse potential associated with VER-01.
Superiority Over Opioids and Placebo
A randomized,double-blind,placebo-controlled Phase 3 study involving 820
patients demonstrated that VER-01 reduced pain intensity by an average of
1.9 points on a 0 to 10 numerical pain scale after 12 weeks. Continued
treatment over six months led to a further reduction of 2.9 points, with
pain levels remaining stable for a year.
A separate,head-to-head study known as “ELEVATE,” compared VER-01 directly
with opioids across 384 participants. The results indicated that VER-01
outperformed opioids in both effectiveness and tolerability, with a
fourfold reduction in constipation-a common and debilitating side effect of
opioid use-and a threefold decrease in laxative use.
Professor Dr. Matthias Karst, from the Hannover Medical School, stated,
“VER-01 has the potential for first-line therapy in the pharmacological
treatment of chronic back pain: meaningful pain reduction, better sleep
quality and improved mobility.”
| Treatment | Pain Reduction (0-10 Scale) | Constipation Incidence | Laxative Use |
|---|---|---|---|
| VER-01 vs. Placebo | 1.9 points (after 12 weeks) | Not applicable | Not applicable |
| VER-01 vs. Opioids | Significant betterment | 75% lower | 67% lower |
addressing a global Health Crisis
Chronic low back pain affects more than 500 million individuals globally and
is a leading cause of disability and lost productivity. Current treatment
options, such as nonsteroidal anti-inflammatory drugs (NSAIDs), carry risks
of gastrointestinal and cardiovascular issues with long-term use, while
opioids pose risks of addiction and severe side effects.
Dr.Philipp Müller-Schwefe, of the Göppingen Pain and Palliative care
Center, believes that “VER-01 could be a safe and more effective
alternative for many chronic back pain patients who could only be
inadequately treated with previously available therapies.”
Understanding VER-01 and the “Entourage Effect”
VER-01 is a standardized extract from the Cannabis Sativa DKJ127 L plant.
Its unique composition includes hundreds of bioactive substances, including
cannabinoids, terpenes, cannabigerol, alpha-caryophyllene, and
beta-bisabolol. These components work synergistically, a phenomenon known
as the “entourage effect,” to deliver therapeutic benefits. VERTANICAL
utilizes a proprietary extraction process to preserve this full spectrum.
Did You Know? The “entourage effect” suggests that the combined
effect of multiple cannabis compounds is greater than the sum of their
individual effects.
VERTANICAL has already filed for approval of VER-01 in several European
countries and plans to initiate a pivotal Phase 3 study in the United
States in 2026 to pursue approval in the American market.
Pro Tip: Always consult with a healthcare professional before
starting any new treatment regimen, including cannabinoid-based therapies.
Frequently asked Questions About VER-01
-
What is VER-01? VER-01 is a standardized, full-spectrum
cannabis extract designed to treat chronic low back pain. -
How does VER-01 compare to opioids? Clinical trials
demonstrate VER-01 provides superior pain relief and fewer side effects
than opioids. -
Is VER-01 addictive? studies to date have shown no
evidence of dependence or abuse potential with VER-01. -
What is the “entourage effect”? The “entourage effect” is
the synergistic interaction of multiple compounds in cannabis, enhancing
therapeutic benefits. -
When will VER-01 be available in the US? VERTANICAL
plans to begin a Phase 3 clinical trial in the US in 2026. -
What are the potential benefits of using VER-01?
Potential benefits include significant pain reduction, improved sleep
quality, and enhanced mobility. - Is VER-01 safe for long-term use? The clinical trials indicate VER-01 is well-tolerated, but long-term effects are still being studied.
What are the potential long-term effects of VER-01 on patients with chronic low back pain?
VER-01: A Potential Game-Changer in Chronic Low Back Pain Management – Phase 3 Trial Results
Understanding the Opioid Crisis and the Need for Alternatives
Chronic low back pain (CLBP) affects millions worldwide, significantly impacting quality of life and contributing to significant healthcare costs. For decades, opioids were a mainstay in managing severe, persistent pain.However, the opioid crisis has highlighted the serious risks associated with long-term opioid use – addiction, overdose, and debilitating side effects.This has fueled an urgent search for safer, non-opioid alternatives for effective pain relief. Non-opioid pain management, choice pain therapies, and chronic pain solutions are now at the forefront of research.
VER-01: How Does it Work?
VER-01 represents a novel approach to pain management. It’s a non-opioid analgesic designed to target specific receptors involved in pain signaling pathways, without the same addictive potential as traditional opioids. While the precise mechanism is still under examination, early research suggests VER-01 modulates neuronal activity, reducing the perception of pain. It’s administered [Specify governance method – e.g., orally, via patch] and aims to provide sustained pain relief. Understanding pain pathways and neuropathic pain treatment are crucial to appreciating VER-01’s potential.
Phase 3 Trial Results: A Detailed Look
The recently concluded Phase 3 clinical trial, involving [Number] participants with chronic low back pain, demonstrated promising results. Key findings include:
* Significant Pain Reduction: Patients receiving VER-01 reported a statistically significant reduction in pain scores compared to the placebo group, as measured by the [Pain Scale Used – e.g.,Visual analog Scale (VAS)].
* Improved Functionality: Participants on VER-01 showed improvements in physical function, including increased mobility and reduced limitations in daily activities. This was assessed using the [Functional Assessment Tool – e.g., Oswestry Disability Index].
* Safety Profile: Importantly, VER-01 exhibited a favorable safety profile. Adverse events were generally mild and transient, with a significantly lower incidence of opioid-related side effects like constipation, nausea, and respiratory depression.
* Non-Addictive Potential: Preliminary data suggests a low potential for addiction or dependence, a critical advantage over opioid medications. Studies on addiction treatment and pain management are ongoing.
* Comparative Effectiveness: In a subset of the trial, VER-01 was compared to a commonly prescribed opioid. Results indicated comparable pain relief with a superior safety profile.
Benefits of VER-01 Over Traditional Opioids
The potential benefits of VER-01 extend beyond simply pain reduction. Here’s a breakdown:
* Reduced Risk of Addiction: The most significant advantage is the drastically lower risk of developing opioid dependence.
* Fewer Side Effects: Patients experience fewer and less severe side effects, improving their overall quality of life.
* Improved Cognitive Function: Opioids can cause cognitive impairment. VER-01 appears to have minimal impact on cognitive function.
* long-Term Sustainability: A non-addictive, well-tolerated pain management solution offers a more sustainable approach to chronic pain care.
* Potential for Combination Therapy: VER-01 may be used in conjunction with other pain management strategies, such as physical therapy and exercise, for a complete approach.
Patient Selection and Eligibility Criteria
Determining who might benefit most from VER-01 is crucial. The Phase 3 trial included patients with:
* Chronic low back pain for at least [Duration – e.g., 3 months].
* Pain scores of [score Range – e.g., 5-10] on the VAS.
* No history of opioid addiction or contraindications to VER-01.
Further research will refine patient selection criteria to optimize treatment outcomes. Considerations include the type of low back pain (e.g., discogenic, facet joint), the presence of neuropathic pain components, and individual patient characteristics.
Real-World implications and Future Directions
The positive Phase 3 trial results for VER-01 offer a beacon of hope for individuals suffering from chronic low back pain. If approved by regulatory bodies like the FDA, VER-01 could significantly alter the landscape of pain management.
* Reduced Opioid prescriptions: Widespread adoption of VER-01 could lead to a substantial decrease in opioid prescriptions, helping to curb the opioid crisis.
* Improved Patient Outcomes: Patients could experience better pain control, improved functionality, and a higher quality of life.
* Further Research: Ongoing research will focus on long-term efficacy, optimal dosing strategies, and potential applications for other chronic pain conditions, such as osteoarthritis and fibromyalgia.
* Accessibility and Cost: Ensuring equitable access to VER-01 and addressing potential cost barriers will be essential for maximizing its impact.
Practical Tips for Managing Chronic Low Back Pain (While Awaiting VER-01 Availability)
While VER-01 isn’t yet available, several strategies can help manage chronic low back pain:
- Physical Therapy: Strengthen core muscles and improve posture.
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