Effectiveness, Safety, and Tolerability of Nabiximols Oromucosal Spray vs Typical Oral Long-Acting Opioid Analgesics in Patients with Severe Neuropathic Back Pain: Analysis of 6-Month Real-World Data from the German Pain e-Registry

Abstract

Objective To compare the effectiveness, safety, and tolerability of add-on nabiximols (NBX) oromucosal spray vs typical oral long-acting opioid (LAO) analgesics in patients with severe (± chronic) peripheral neuropathic back pain poorly responsive to other treatments. Methods Retrospective analysis of anonymized, propensity score–matched data from the German Pain e-Registry of adult outpatients who initiated NBX or LAO between March 2017 and March 2020. Results Data were analyzed from propensity score–matched patients treated with NBX (n = 655) or LAO (n = 655): mean age ≈51 years; 57% female; mean pain duration ≈2.6 years; chronic pain 61%; severe dysfunctional pain 93%. At 6 months, NBX was noninferior to LAO for overall symptom relief, based on the least-squares mean difference between cohorts in change from baseline in patient-reported, pain-related aggregated nine-item scale scores (−27.84%; 95% confidence interval [CI] −29.71 to −25.96; P < 0.001) and individual pain-related scale scores. Subsequent prespecified superiority analysis of the primary endpoint showed that NBX was superior to LAO: all secondary endpoints measuring symptoms of pain and physical function improved significantly with NBX and LAO, with between-group differences favoring NBX (all P < 0.001). Fewer patients treated with NBX than LAO experienced treatment-related adverse events (25.5% vs 76.0%; P < 0.001) or discontinued treatment because of treatment-related adverse events (7.9% vs 29.3%; P < 0.001). Conclusion Within study limitations (e.g., observational design, all potential biases), add-on NBX was superior to and better tolerated than add-on treatment with typical oral LAO analgesics in patients with neuropathic back pain inadequately controlled by recommended/established systemic therapies.

Combinations of Cannabidiol and Δ9-Tetrahydrocannabinol in Reducing Chemotherapeutic Induced Neuropathic Pain

“…These data are also consistent with reports that CBD is an antagonist at cannabinoid receptors 1 and 2, and can blunt the effects of THC [ 23 , 24 , 25 ]. Based upon the large number of studies that have reported that nabiximols (mixtures of approximately 1:1 THC:CBD) have antinociceptive properties, it was unexpected that we did not see a larger difference in anti-nociceptive potential with different ratios [ 14 , 15 , 16 , 17 ]. Our data suggest that there is little effect of CBD on reducing neuropathic pain, and that most of the reduction in pain can be attributed to THC, although CBD may help to augment the impact of THC.…”

“…These products typically have varying ratios of THC:CBD but there are few studies that have investigated the optimal ratios of the two primary cannabinoids for treating medical conditions. Most studies that have investigated the interactions between these two cannabinoids have limited their scope to the 1:1 ratio typically found in nabixmols (Sativex ® ) [ 14 , 15 , 16 , 17 ]. While our data suggest that a 1:1 ratio of CBD to THC may not be optimal, there is a benefit of including CBD in combination with THC to reduce neuropathic pain, as lower levels of THC produced a reduction in sensitivity when CBD was included, this is especially true for the botanical extracts.…”

“…Furthermore, the anti-nociceptive effects of these varying ratios of THC and CBD remain underexplored. Instead, studies have largely focused on THC:CBD co-administered at 1:1 ratios, commonly found in the European-approved Sativex (nabiximols) that has been shown to be effective at treating pain in patients with certain conditions [ 14 , 15 , 16 , 17 ]. We therefore set out to assess how different combinations of THC and CBD, as both pure compounds and from unfractionated plant extracts, affect mechanical hypersensitivity in a mouse model of chemotherapeutic-induced peripheral neuropathy (CIPN).…”

Cannabinoide Arzneimittel bei Krebspatient*innen

“…Therapeutische Effekte Laut Begleiterhebung einer Datenerhebung zur Verordnung zwischen 2017 und 2022 [6] und anderen Beobachtungsstudien [29,33] verbessern sich unter THC chronische Schmerzen, Schlaflosigkeit, Schwindel, Appetitlosigkeit und die Stimmung. ▶Tab.…”

Cannabinoide Arzneimittel bei Krebspatient*innen

“…[29] verbessern sich unter THC chronische Schmerzen, Schlaflosigkeit, Schwindel, Appetitlosigkeit und die Stimmung. Tab.…”