Sativex (nabiximols) / Ipsen, Jazz, Chiesi, Bayer, Almirall, NeoPharm, Biopas Group - LARVOL DELTA

UK Medical Cannabis Registry: An Updated Analysis of Cannabis-Based Medicinal Products for Multiple Sclerosis. (PubMed, Med Cannabis Cannabinoids) - "Although nabiximols is licensed for MS-induced spasticity, cannabis-based medicinal products (CBMPs) have also displayed promising therapeutic potential for managing pain, sleep, and anxiety...CBMP treatment over 24 months was associated with improvements in health-related quality of life and was well tolerated in patients with MS. Future randomised controlled trials with more representative study populations are needed to establish causal relationships."

Journal • CNS Disorders • Fatigue • General Anxiety Disorder • Mood Disorders • Movement Disorders • Multiple Sclerosis • Pain • Psychiatry

Randomised Controlled Trial Evidence on Medicinal Cannabis for Treatment of Mental Health and Substance Use Disorders: A Scoping Review. (PubMed, Clin Drug Investig) - "Despite growing interest, substantial heterogeneity limits current evidence for medicinal cannabis in mental health. This review highlights key gaps, underscoring the need for robust, well-powered RCTs with extended follow-up to clarify its role in the management of mental ill health."

Journal • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Autism Spectrum Disorder • CNS Disorders • Depression • Epilepsy • Genetic Disorders • Mental Retardation • Mood Disorders • Movement Disorders • Multiple Sclerosis • Nicotine Addiction • Obsessive-Compulsive Disorder • Post-traumatic Stress Disorder • Psychiatry • Schizophrenia • Substance Abuse • Tobacco Addiction • Tourette Syndrome

Sativex Oromucosal Spray in Patients with Chronic Graft Versus Host Disease: Effect on Sclerodermal Features and Refractory Muscle Cramps (ASH 2024) - "At Sativex initiation, 24 patients experienced muscle cramps refractory to pregabalin and/or baclofen. This improvement, alongside a favorable AEs profile, makes this treatment an interesting strategy for this patient group. Further prospective studies are warranted to characterize the use of cannabinoids in patients with cGVHD."

Clinical • Bone Marrow Transplantation • Chronic Graft versus Host Disease • CNS Disorders • Graft versus Host Disease • Immunology • Movement Disorders • Multiple Sclerosis • Scleroderma • Systemic Sclerosis • Xerostomia

Update on Pharmacology in Tourette's Disorder (AACAP 2025) - "There are only 3 pharmacological interventions FDA-approved for TD: pimozide, haloperidol, and aripiprazole, and as such, most treatments are used off-label...She will also describe recent trials that did not meet their primary end points (eg, deutetrabenazine, nabiximols), but may still hold promise for certain individuals/subgroups with TD... There is a great need for new medications for TD that are as effective for tics as antipsychotics, but without the potential short and long-term side effects associated with typical and atypical antipsychotics. Recently, new medications currently in Phase IIb and III trials are showing great promise!.TD, TICD, PPC"

CNS Disorders • Mental Retardation • Movement Disorders • Psychiatry • Tourette Syndrome

Anxiety and depressive symptoms in regular cannabis users: A literature review (ECNP 2025) - "Pharmacological options such as gabapentin, dronabinol, and nabiximols have demonstrated some efficacy for withdrawal symptoms. The use of venlafaxine in patients with depression and cannabis use is discouraged due to potential adverse outcomes [3]... Regular cannabis use is associated with increased severity and prevalence of depressive and, to a lesser extent, anxiety symptoms. This relationship appears bidirectional and is mediated by various biological and psychosocial factors. Effective treatment requires integrated approaches that address both cannabis use and co-occurring affective symptoms."

Review • CNS Disorders • Depression • Mood Disorders • Psychiatry • Substance Abuse • Suicidal Ideation

THE COMBINATION OF CANNABINOIDS AND RADIOTHERAPY DEMONSTRATES STRONG ANTI-TUMOR EFFECTS ON HUMAN GLIOMA CELLS (EANO 2025) - "MATERIAL AND METHODS In this study, Δ9-tetrahydrocannabinol (Δ9-THC), cannabidiol (CBD)-containing Sativex, and a GBM cell line (U87-MG) were utilized...This combination therapy may offer a promising approach, particularly in treating high-grade gliomas resistant to current treatments. However, these findings need to be supported by in vivo experiments, and the data obtained should be further evaluated in clinical studies to establish a safe and effective therapeutic profile."

Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor

Peripheral neuromodulation in spasticity-plus syndrome: effects of pulsed radiofrequency on tonic-painful disorders in multiple sclerosis. (PubMed, Front Neurol) - "Despite multiple pharmacological therapies (baclofen, opioids, nabiximols), symptom control remained poor. PRF provides safe, repeatable peripheral neuromodulation without neuro-destructive effects, enabling multimodal, patient-centered care. Although based on a single case, these findings support the clinical value of the SPS construct and suggest PRF as a promising complementary strategy in MS-related disability."

Journal • CNS Disorders • Movement Disorders • Multiple Sclerosis • Neuralgia • Orthopedics • Pain • Urology

Cannabis decoction after nabiximols for MS-related spasticity, spasms and pain: a single-centre study (ECTRIMS 2025) - "Cannabis decoction demonstrated efficacy in reducing spasticity and pain. It may represent a viable therapeutic alternative for PwMS who discontinue nabiximols, with high rate of treatment persistence."

Clinical • CNS Disorders • Movement Disorders • Multiple Sclerosis • Pain

ABCB1 polymorphisms are associated with clinical response to nabiximols in patients with multiple sclerosis-related spasticity. (PubMed, J Cannabis Res) - No abstract available

Journal • CNS Disorders • Movement Disorders • Multiple Sclerosis • ABCB1

Cannabinoids in Chronic Pain: Clinical Outcomes, Adverse Effects and Legal Challenges. (PubMed, Neurol Int) - "Quantitative data show that discontinuation rates range from 4.3% at low-dose CBD to 12.9% at high-dose CBD, compared with 3.5% on placebo, while nabiximols (THC + CBD spray) are associated with dizziness in 25% of patients, somnolence in 8%, and treatment discontinuation in 12%...Overall, cannabinoids provide modest, condition-specific analgesia and should be considered adjunctive rather than first-line options, reserved for patients unresponsive to conventional therapy. Future progress requires standardized formulations, harmonized international regulations, long-term safety data, and large-scale randomized controlled trials to clarify their role in evidence-based pain management."

Adverse events • Clinical data • Journal • Review • CNS Disorders • Fibromyalgia • Immunology • Movement Disorders • Multiple Sclerosis • Musculoskeletal Diseases • Musculoskeletal Pain • Neuralgia • Osteoarthritis • Pain • Rheumatology

Population pharmacokinetic modelling revealed large variability in oromucosal absorption of Δ9-tetrahydrocannabinol in older patients with poor appetite. (PubMed, Br J Clin Pharmacol) - "The parent-metabolite model describes and quantifies the pharmacokinetics of oromucosally administered THC in older medical patients with poor appetite. The covariate analysis did not show any clinically significant effect on pharmacokinetic parameters of THC or THC-OH."

Journal • PK/PD data

Emerging pharmacological strategies for the treatment of cannabis use disorder. (PubMed, Expert Opin Pharmacother) - "Agents discussed include gabapentin, N-acetylcysteine, synthetic cannabinoids, fatty acid amide hydrolase (FAAH) inhibitors, orexin receptor antagonists, and psychedelics...Novel compounds targeting endocannabinoid tone and motivational circuits show promise, but significant research is still needed. Future progress depends on better integration with behavioral care, trial stratification by clinical phenotype, and increased investment in translational research to move beyond withdrawal symptom management toward sustained recovery."

Journal • Substance Abuse

Sativex (Nabiximols) on the sleep symptoms of agitated late-stage dementia patients - A study comparing questionnaire-based and wearable-based results (WSS 2025) - "Care home-dwelling late-stage agitated dementia patients appeared to sleep poorly with very low sleep regularity, compared with people with similar dementia severity or of similar age. Despite not sufficiently powered, preliminary NPI-NH-based results of this study suggest sleep symptoms might be ameliorated following 4 weeks of nabiximol treatment. Although the improvements were not corroborated in device-based outcomes, the longitudinal and objective device-based variables provide holistic information regarding the overall circadian rhythmicity change, which might facilitate the development of novel therapeutic targets for late-stage dementia patients."

Clinical • Alzheimer's Disease • CNS Disorders • Dementia • Psychiatry • Sleep Disorder

Extended-release cannabinoid nanoparticles for chronic pain, anxiety, addiction, and CNS disorders (ACS-Fall 2025) - "Progress has been made on several fronts on the use of cannabinoids for medical use such as Charlotte's Web (CW) being used for childhood epilepsy through development by patient advocacy groups, and as a FDA-approved drug, Epidiolex® (Jazz Pharmaceuticals/GW Pharma) for a rare form of childhood epilepsy, Dravet syndrome. Sativex® (Jazz Pharmaceuticals/GW Pharma), a drug containing equal proportions of D9-THC and CBD, is approved as a second-line treatment for Multiple Sclerosis (MS) associated spasticity in over 24 other countries outside of the US...We are progressing an extended release combination product of CBD and low dose Naltrexone in biodegradable polymer nanoparticles through rigorous Phase 2 clinical trials. With a total addressable target market of $93 billion for pain, addiction, anxiety and other CNS-related indications, our innovations are positioned to make a transformative impact in cannabinoid-based medicine."

Addiction (Opioid and Alcohol) • Cachexia • CNS Disorders • Epilepsy • Glaucoma • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders • Movement Disorders • Multiple Sclerosis • Muscle Spasticity • Ophthalmology • Pain • Psychiatry

SENS-NMO: A Phase IIb Study of Nabiximols for Spasticity Due to Neuromyelitis Optica Spectrum Disorders (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Michael, Levy M.D.,Ph.D. | N=44 ➔ 0 | Trial completion date: Sep 2026 ➔ Sep 2027 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Apr 2026 ➔ Apr 2027

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • CNS Disorders • Movement Disorders • Muscle Spasticity • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

The effects of nabiximols (Sativex®) on spasticity and non-motor symptoms in chronic spinal cord injury (SCI): a longitudinal prospective study. (PubMed, Spinal Cord Ser Cases) - P4 | "Nabiximols may effectively reduce spasticity in individuals with SCI resistant to conventional therapies. Given the significant impact of spasticity associated with SCI, it could be considered a viable add-on therapy for this population."

Journal • Observational data • CNS Disorders • Depression • Movement Disorders • Neuralgia • Orthopedics • Pain • Psychiatry

A 1:1 combination of cannabidiol and Δ9-tetrahydrocannabinol inhibit toll-like receptor 7- and 8-mediated inflammation in human immune cells. (PubMed, Eur J Pharmacol) - "In this study we focused on two clinically relevant plant-derived (phyto) cannabinoids, cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC), given that cannabinoid-based therapeutics containing these compounds are currently available in the form of sativex® (nabiximols) and epidiolex®. Data presented herein indicate that CBD and THC, particularly when delivered in a 1:1 combination, can act as TLR7/8 immunomodulatory drugs to dampen inflammation in macrophages and PBMCs. This study provides evidence that phytocannabinoids target TLR7/8-induced viral signalling on endosomal compartments to control inflammation in immune cells."

Journal • Immunology • Infectious Disease • Inflammation • CXCL10 • IRF7 • TLR7 • TLR8 • TNFA

Nabiximols oromucosal spray in patients with chronic graft-versus-host disease: effects on sclerodermatous features and refractory muscle cramps. (PubMed, Bone Marrow Transplant) - No abstract available

Journal • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Scleroderma • Systemic Sclerosis

Preclinical evaluation of cannabidiolic acid as a neuroprotective agent in TDP-43 transgenic mice, an experimental model of amyotrophic lateral sclerosis. (PubMed, Biomed Pharmacother) - "Plant-derived cannabinoids, including Δ9-THC, cannabinol, and Sativex-like combinations, have shown neuroprotection in preclinical ALS models. In conclusion, CBDA was the most effective of the five phytocannabinoids studied and outperformed riluzole in ALS models. These findings support further clinical evaluation of CBDA for ALS treatment."

Journal • Preclinical • Amyotrophic Lateral Sclerosis • CNS Disorders • TARDBP

ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: University of Birmingham | N=234 ➔ 120

Enrollment change • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MGMT

Sativex (nabiximols) for the treatment of Agitation & Aggression in Alzheimer's dementia in UK nursing homes: a randomised, double-blind, placebo-controlled feasibility trial. (PubMed, Age Ageing) - "Despite significant COVID-19 pandemic related challenges, administering nabiximols through oral mucosa to advanced ad patients with agitation demonstrated feasibility and safety. These findings support a larger confirmatory efficacy trial to evaluate the potential therapeutic efficacy of nabiximols for agitation in ad."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Dementia • Infectious Disease • Novel Coronavirus Disease • Psychiatry

Cannabinoids for Medical Purposes in Children: A Living Systematic Review. (PubMed, Acta Paediatr) - "These findings will continue to be updated to inform practice and reveal knowledge gaps for future research."

Journal • Review • Autism Spectrum Disorder • Chemotherapy-Induced Nausea and Vomiting • CNS Disorders • Epilepsy • Genetic Disorders • Oncology • Pain

Pharmacokinetics and Side Effects of Δ9-Tetrahydrocannabinol and Cannabidiol in Patients with Different Stages of CKD. (PubMed, Kidney Int Rep) - "We aimed to investigate the pharmacokinetics and side effects of a single dose of Sativex, corresponding to 5.4 mg Δ9-tetrahydrocannabinol (THC) and 5 mg cannabidiol (CBD), in patients with CKD stages 4 and 5 compared with healthy volunteers (controls)...Total exposure to THC, CBD, and metabolites was higher in patients with CKD stages 4 and 5 compared with controls, and side effects may be more pronounced; however, the intersubject variability was high. If cannabis products are administered to patients with severe CKD, caution is needed."

Adverse events • Journal • PK/PD data • Chronic Kidney Disease • Nephrology • Renal Disease

Efficacy of cannabidiol alone or in combination with Δ-9-tetrahydrocannabinol for the management of substance use disorders: An umbrella review of the evidence. (PubMed, Addiction) - "Cannabidiol (CBD) monotherapy does not appear to be efficacious for treatment of substance use disorders. CBD primarily exhibits effects on cannabis withdrawal and craving when combined with Δ-9-tetrahydrocannabinol (THC). Existing data on the efficacy of CBD alone with regard to other outcomes related to substance use disorders are limited."

Journal • Review • Psychiatry

Current and Potential Use of Biologically Active Compounds Derived from Cannabis sativa L. in the Treatment of Selected Diseases. (PubMed, Int J Mol Sci) - "Epidiolex®, a 99% pure oral CBD extract, has been approved by the FDA for the treatment of epilepsy. Nabiximols (Sativex) is an oromucosal spray containing equal volume of THC and CBD, and it is commonly used as an add-on treatment for unresponsive spasticity in multiple sclerosis (MS) patients. Several in vitro and in vivo studies have also shown that cannabinoids can be used to treat various types of cancer, such as melanoma and brain glioblastoma; the first positive clinical trials on the anticancer effect of a THC:CBD blend with temozolomide (TMZ) in the treatment of highly invasive brain cancer are very promising...It is postulated that cannabis extracts can be used in the treatment of many other diseases such as systemic lupus erythematosus, type 1 diabetes, or various types of neurological disorders, e.g., Alzheimer's disease. The aim of this review is to outline the current state of knowledge regarding currently used medicinal preparations derived from..."

Journal • Review • Alzheimer's Disease • Brain Cancer • CNS Disorders • CNS Tumor • Diabetes • Epilepsy • Glioblastoma • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Melanoma • Metabolic Disorders • Movement Disorders • Multiple Sclerosis • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Solid Tumor • Systemic Lupus Erythematosus • Type 1 Diabetes Mellitus