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

Multimodal Pharmacologic Strategies for Chronic Cancer Pain: A Systematic Review. (PubMed, Cureus) - "In one trial, duloxetine was associated with clinically meaningful pain-response rates, although its primary mean pain-score analysis was not statistically significant. Low-dose gabapentin plus imipramine reduced pain and rescue-morphine use. Pregabalin reduced the morphine dose required to maintain pain control in one crossover trial, while other pregabalin studies showed numerical or non-significant benefits. Neither nabiximols trial met its primary efficacy endpoint, and nefopam did not significantly improve pain response or morphine consumption...Overall, the evidence remains heterogeneous and insufficient to support a standard multimodal pharmacological regimen. Selected antidepressant and gabapentinoid strategies, particularly in neuropathic cancer pain, may benefit selected patients."

Journal • Review • Addiction (Opioid and Alcohol) • Oncology • Pain

Current role of cannabis in therapeutics: A critical perspective. (PubMed, Farm Hosp) - "For spasticity in multiple sclerosis, preparations such as nabiximols reduce patients' perception of symptoms, although there is a high discontinuation rate due to lack of efficacy or adverse effects...In conclusion, although cannabis may offer certain benefits, its integration into modern clinical practice should be cautious, individualized, and carried out under strict clinical supervision. The analysis of real-world use data will undoubtedly provide valuable insights."

Journal • Anorexia • Chemotherapy-Induced Nausea and Vomiting • CNS Disorders • Epilepsy • Fibromyalgia • Glaucoma • Mood Disorders • Movement Disorders • Multiple Sclerosis • Musculoskeletal Pain • Neuralgia • Ophthalmology • Pain • Pediatrics • Psychiatry • Rheumatology

Cannabis-Based Medicine (Sativex) in the Treatment of Pain in Kidney Failure (ANZCTR) - P4 | N=100 | Terminated | Sponsor: Northern Alberta Renal Program | Phase classification: P ➔ P4 | Not yet recruiting ➔ Terminated

Phase classification • Trial termination • Chronic Kidney Disease • Nephrology • Pain • Renal Disease

Neuropharmacology of Cannabinoids: A Comprehensive Review of Preclinical and Clinical Evidence for Hemp-Derived Extracts and Active Compounds. (PubMed, Pharmaceuticals (Basel)) - "Moderate-certainty evidence supports nabiximols for multiple sclerosis spasticity and small benefits in selected chronic neuropathic pain populations...Key risks include cannabis use disorder, cognitive and psychiatric effects, cardiovascular events, sedation, high-dose CBD hepatotoxicity, and drug interactions. Rigorous, long-term, product-standardized trials are needed."

Journal • Preclinical • Review • Alzheimer's Disease • Anesthesia • Anorexia • Cardiovascular • Chemotherapy-Induced Nausea and Vomiting • CNS Disorders • Cognitive Disorders • Epilepsy • Human Immunodeficiency Virus • Huntington's Disease • Infectious Disease • Insomnia • Mental Retardation • Movement Disorders • Multiple Sclerosis • Neuralgia • Pain • Parkinson's Disease • Psychiatry • Sleep Disorder • Substance Abuse • GPR55 • PPARG

Cannabis, the Good, the Bad and the Psychotic (WFSBP 2026) - "In addition to treatment of psychosis it provides individual therapy (CBT/motivational approaches) as well as weekly on-line group, and where appropriate Sativex to cover cannabis withdrawal...Many studies show that teenagers who use cannabis heavily are less likely to pass school or university exams and are less successful in work. There is some evidence that people who heavily use cannabis for decades may show IQ decline which does not reverse fully after stopping cannabis – however, this latter remains controversial."

Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Mental Retardation • Mood Disorders • Post-traumatic Stress Disorder • Schizophrenia

A matter of formulation: Efficacy and tolerability of nabiximols and cannabis decoction for the treatment of multiple sclerosis-related spasticity. (PubMed, Mult Scler Relat Disord) - "Both nabiximols and cannabis decoction are effective for MS-related spasticity. Cannabis decoction may represent a viable option for patients who do not respond to or tolerate nabiximols. Differences in cannabinoid composition and pharmacokinetics may explain variations in outcomes. Prospective studies are needed to confirm these findings and optimize treatment strategies."

Journal • CNS Disorders • Movement Disorders • Multiple Sclerosis • Pain

Effects of Sativex® Versus Placebo on Glucagon-like Peptide-1, Total Ghrelin, and Subjective Appetite in Older Adults with Poor Appetite: A Protocolized Secondary Analysis of a Double-Blind, Randomized, Placebo-Controlled Crossover Trial. (PubMed, Nutrients) - P1, P1/2 | "In conclusion, no statistically significant differences were detected between Sativex® and placebo in postprandial GLP-1, total ghrelin, or subjective appetite over time in older adults with poor appetite. Similarly, no statistically significant associations were observed between plasma concentrations of THC and its metabolites and GLP-1, total ghrelin, or subjective appetite."

Clinical • Journal

Nabiximols in Multiple Sclerosis: Beyond Spasticity-An Exploratory Systematic Review and Meta-Analysis of Symptomatic Outcomes. (PubMed, Med Sci (Basel)) - " Beyond spasticity, nabiximols may represent a signal of benefit for bladder function, sleep disruption, spasm quality, and gait function in MS, in line with the "spasticity-plus" concept. However, the evidence certainty was low to very low, and these findings should be considered exploratory."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Movement Disorders • Multiple Sclerosis • Sleep Disorder

Clinical immunomodulatory effects of cannabinoids in autoimmune diseases in internal medicine : A literature review (PubMed, Rev Med Interne) - "The development of cannabinoid-derived drugs, such as dronabinol, nabiximols, and cannabidiol, is based on two main principles: their role in modulating the release of presynaptic neurotransmitters and their anti-inflammatory and analgesic effects, demonstrated in experimental models and in humans. However, clinical studies evaluating their effects in autoimmune diseases remain scarce. The available, heterogeneous data underscore the need for further basic and clinical research to better characterize these mechanisms and their therapeutic implications."

Journal • CNS Disorders • Epilepsy • Immunology • Inflammatory Arthritis • Lupus • Movement Disorders • Multiple Sclerosis • Neuralgia • Pain • Scleroderma • Systemic Sclerosis • CD4

Cannabis sativa phytochemicals in cancer therapy: molecular mechanisms and therapeutic potential. (PubMed, Front Pharmacol) - "Clinical formulations such as Nabiximols provide translational evidence of cannabinoid synergy, although outcomes remain context-dependent...Future research should prioritize mechanistic studies, rational phytochemical combinations, and innovative drug delivery systems. Taken together, Cannabis sativa phytochemicals emerge as promising molecular entities with the potential to reshape integrative oncology, provided their therapeutic promise is matched with rigorous, evidence-based evaluation."

Journal • Review • Melanoma • Oncology • Pancreatic Cancer • Solid Tumor

Nabiximols improves sleep architecture in multiple sclerosis: a prospective polysomnographic study (EAN 2026) - No abstract available

Clinical • CNS Disorders • Multiple Sclerosis

Therapeutic Drug Monitoring of Cannabinoids: Therapeutic Reference Ranges for Delta-9-tetrahydrocannabinol in Medical Cannabis, Nabiximols, Dronabinol and Nabilone. (PubMed, Pharmacopsychiatry) - "In conclusion, relatively low concentrations may be sufficient to achieve therapeutic effects across all substances studied, with medical cannabis demonstrating these effects at lower concentrations than typically observed in recreational use. Nevertheless, adverse effects at therapeutic reference ranges cannot be excluded."

Journal • Chemotherapy-Induced Nausea and Vomiting • CNS Disorders • Diabetic Neuropathy • Movement Disorders • Multiple Sclerosis • Neuralgia • Pain • Peripheral Neuropathic Pain

Efficacy of Sativex® on Pain, Spasticity, and Disability in Patients With Multiple Sclerosis: A Systematic Review and Meta-Analysis. (PubMed, Pharmacol Res) - "In addition, a modest but statistically significant improvement in disability, assessed by Expanded Disability Status Scale (EDSS), was detected (SMC: -0.17, 95% CI -0.28 to -0.07, p = 0.0015). Overall, evidence suggests that Sativex may represent an effective therapeutic option for the management of pain and spasticity in patients with MS, with potential benefits for functional disability."

Journal • Retrospective data • Review • CNS Disorders • Immunology • Movement Disorders • Multiple Sclerosis • Neuralgia • Pain

ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: University of Birmingham | Trial primary completion date: Apr 2026 ➔ Sep 2026

Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MGMT

Cannabinoids in the Treatment of Chemotherapy-Induced Peripheral Neuropathy: A Systematic Review of Randomized Controlled Trials. (PubMed, J Pain Palliat Care Pharmacother) - "Interventions included nabiximols, oral cannabidiol, and topical cannabidiol...Current evidence is insufficient to support the routine use of CBMPs for CIPN. Larger, methodologically rigorous trials with standardized outcomes and longer follow-up are required."

Journal • Review • Fatigue • Neuralgia • Oncology • Pain • Peripheral Neuropathic Pain • Xerostomia

Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain (clinicaltrials.gov) - P2 | N=320 | Recruiting | Sponsor: VA Office of Research and Development | Trial completion date: Jun 2027 ➔ May 2029 | Trial primary completion date: Jun 2027 ➔ Sep 2028

Trial completion date • Trial primary completion date • Neuralgia • Pain • Peripheral Neuropathic Pain

Cannabidiol in Neurology: Current Insights and Translational Perspectives. (PubMed, Pharmaceuticals (Basel)) - "To date, the only drug that consists solely of highly purified CBD is Epidiolex, which is used in the management of severe forms of epilepsy such as Dravet syndrome and Lennox-Gastaut syndrome. Another legal medication containing CBD (albeit with the addition of THC) is Sativex, used to alleviate spasticity in multiple sclerosis...However, much attention should be paid as CBD-driven drug-drug interactions have been reported. This review article aims to assess the outcomes of preclinical and clinical research on CBD's effects in various neurological conditions while also addressing potential risks and concerns related to its use."

Journal • Review • Alzheimer's Disease • Cardiovascular • CNS Disorders • Epilepsy • Movement Disorders • Multiple Sclerosis • Neuralgia • Pain • Parkinson's Disease • Vascular Neurology

Pain in multiple sclerosis: clinical phenotypes and therapeutic strategies - a narrative review. (PubMed, Pain Rep) - "Evidence for pharmacological interventions - such as anticonvulsants, tricyclic antidepressants, muscle relaxants, corticosteroids for acute optic neuritis, and nabiximols for spasticity - is limited, with few trials addressing specific pain subtypes...Pain is common and disabling across all MS phenotypes but is often insufficiently addressed in clinical practice. A mechanism-based classification combined with individualized, multimodal treatment offers the most promising framework to improve patient outcomes."

Journal • CNS Disorders • Depression • Fatigue • Fibromyalgia • Migraine • Movement Disorders • Multiple Sclerosis • Musculoskeletal Pain • Neuralgia • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Psychiatry • Rheumatology • Sleep Disorder

Nabiximols improves sleep architecture in multiple sclerosis: A prospective polysomnographic study. (PubMed, Neurotherapeutics) - "Our prospective study reported a significant sleep disruption in MS and a great improvement in sleep parameters following a 6-week trial of Nabiximols, as indicated by LMMs using PSQI score and PSG measures. We suggest broadening the therapeutic indications of nabiximols to also include individuals with MS who experience significant sleep disruption."

Journal • CNS Disorders • Multiple Sclerosis • Sleep Disorder

Clinical Manifestations. (PubMed, Alzheimers Dement) - "Nocturnal sleep appeared commonly poor and irregular in this population, and the irregularity may not be captured by questionnaires. Clinical trials could consider applying wearables as alternative measurements, which might be able to offer information to complement questionnaire-based results and to explore novel therapeutic targets."

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

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