Sativex

AIM: Cannabis-based medication has recently been made available in the NHS for reducing pain and spasticity in patients with multiple sclerosis (MS). The currently available preparation of Sativex (nabiximols) contains a combination of botanical cannabis extracts with cannabidiol (CBD) and tetrahydrocannabinol (THC) with almost equal amounts in addition to minor cannabinoids and terpenoids and is delivered via an oro-mucosal spray. The present study aims to examine the use and trends in prescribing cannabinoid-based Sativex to control pain in patients diagnosed with MS...

Background: Over the last years, there is a dramatic increase in the use of medical cannabis products for an expanding range of clinical indications. The type of the drug product and its administration route affect substantially the rate and the extent of absorption of cannabinoids and the effects induced by them in the patients. The current challenge for the cannabis pharmaceutical industry is to develop formulations that allow predictable and stable absorption of cannabinoids. This article reports the results of the clinical trial that investigated the pharmacokinetics (PKs) of innovative cannabis products in healthy volunteers...

Spasticity and its related symptoms of spasms, pain, sleep disturbance and bladder dysfunction are common in persons with multiple sclerosis (MS) and may be interconnected through a common pathophysiology and/or may trigger and worsen each other. Tetrahydrocannabinol-cannabidiol (nabiximols) oromucosal spray (Sativex) is an add-on treatment for adults with moderate-to-severe MS spasticity who fail to respond adequately to conventional oral medications. There is evidence that nabiximols can ameliorate spasticity-associated symptoms irrespective of its effect on spasticity...

Aim: This prospective, multicenter, open-label, noninterventional 12-week study investigated the effectiveness and tolerability of add-on nabiximols oromucosal spray (Sativex® ) in the real-world setting in Germany. Patients & methods: The main analysis set comprised 51 adult patients (49 nabiximols responders) with multiple sclerosis (MS) spasticity. Results: The mean overall goal attainment scale score (primary outcome measure) increased by 46% from baseline to week 12 (35.2 vs 51.4; p < 0...

Sativex is a cannabis-based medicine that comes in the form of an oromucosal spray. It contains equal amounts of Δ9-tetrahydrocannabinol and cannabidiol, two compounds derived from cannabis plants. Sativex has been shown to have positive effects on symptoms of amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and sleep disorders. It also has analgesic, antiinflammatory, antitumoral, and neuroprotective properties, which make it a potential treatment option for other neurological disorders...

BACKGROUND: Glioblastoma (GBM) is the most common adult malignant brain tumour, with an incidence of 5 per 100,000 per year in England. Patients with tumours showing O6 -methylguanine-DNA methyltransferase (MGMT) promoter methylation represent around 40% of newly diagnosed GBM. Relapse/tumour recurrence is inevitable. There is no agreed standard treatment for patients with GBM, therefore, it is aimed at delaying further tumour progression and maintaining health-related quality of life (HRQoL)...

OBJECTIVE: Nabiximols is used for treating various symptoms associated with multiple sclerosis (MS). Nabiximols is also being investigated as a potential treatment medication for individuals with cannabis use disorder (CUD). A variety of investigations have shown that, at low doses, nabiximols is overall well tolerated for MS treatment. However, due to tolerance, the management of CUD would likely require much higher doses of nabiximols to be effective. The effects of high doses of nabiximols on clinical laboratory tests remain unclear...

Background: In this review, we provide an updated assessment of available evidence on the pharmacokinetics (PK) of CBD and explore the impact of different factors on PK outcomes. Materials and Methods: This systematic review and meta-regression analysis was preregistered (PROSPERO: CRD42021269857). We systematically searched Medline, Embase, PsycInfo, and Web of Science Core Collection up to November 19, 2022. Trials of CBD in healthy adults were included if they reported at least one of the PK parameters of interest, including Tmax , Cmax , AUC0-t , AUC0-inf , and T1/2 , in serum or plasma...

BACKGROUND: Spasticity affects 54% of multiple sclerosis (MS) patients at disease onset, but this rate gradually increases with disease progression. Spasticity does not fully respond to standard treatment in one-third of the patients. OBJECTIVE: Our systematic review and meta-analysis assessed whether add-on nabiximols, can improve MS-associated refractory spasticity. METHODS: The systematic literature search was performed in Web of Science, MEDLINE, Scopus, CEN- TRAL, and Embase, on 15/10/2021, without restrictions...

BACKGROUND: Nabiximols is a commercially available cannabinoid buccal spray containing 2.7 mg Δ9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD) per spray. It is approved by Health Canada for adults with cancer pain or spasticity/neuropathic pain related to multiple sclerosis. Despite a lack of published studies regarding the use of nabiximols in children, it is being used in clinical practice for indications of pain, nausea/vomiting, and spasticity. OBJECTIVE: To describe the use of nabiximols in children...

PURPOSE: Co-design has previously been used to design custom assistive devices, involving the end user in the process to ensure the device meets their needs. From devices previously created, designs could be re-used and modified to meet variations in the needs of other individuals with similar clinical needs. This service evaluation explored the re-usability of a holder for helping administer the spray medication Sativex, for individuals with multiple sclerosis. METHODS: This evaluation was conducted in a UK based Rehabilitation Engineering NHS department...

BACKGROUND AND AIM: Malnutrition in older patients is linked to poor appetite. Cannabis-based medicine may have orexigenic properties in older patients, but this has to our knowledge never been investigated. In older patients, uncertainty applies to the accuracy of estimated glomerular filtration rate (eGFR) based on creatinine, which is crucial for medication prescribing. In older patients with poor appetite, the study aims 1) to assess the efficacy of Sativex® (8.1 mg delta-9-tetrahydrocannabinol (THC) and 7...

BACKGROUND: To provide a comprehensive assessment of the treatment effects of nabiximols oromucosal spray on multiple sclerosis spasticity in two clinical trials, GWSP0604 and SAVANT. METHODS: Both studies enriched for responders before randomization, defined by a ≥20% improvement in Spasticity 0-10 numeric rating scale (NRS) score. Additionally, SAVANT used randomized re-titration following washout. Spasticity NRS outcomes, spasm count, and modified Ashworth scale (MAS) scores were analyzed...

Background: Detecting the presence of Δ9 -THC and CBD is mainly done through venous blood sampling, but other methods are becoming available. Oromucosal administration of Δ9 -THC and CBD is less studied than inhalation, but this mode of administration is growing. In this study, we analyze samples obtained through invasive and noninvasive methods in a cohort of patients given oromucosally administered Δ9 -THC and CBD to gain understanding in the strengths and weaknesses of the various detection methods...

BACKGROUND: Spasticity and urinary disturbances can profoundly impact the daily lives of persons with multiple sclerosis (pwMS). Cannabis has been associated with improvement in sphincteric disturbances. To our knowledge, few studies have evaluated the effect of nabiximols oromucosal spray (Sativex®) on urinary disturbances by instrumental methods. OBJECTIVES: This longitudinal study was conducted to assess the effect of nabiximols oromucosal spray on urinary disturbances by clinical and urodynamic evaluation in pwMS...

BACKGROUND: Nabiximols (Sativex®) is a cannabinoid approved for multiple sclerosis (MS)-related spasticity. Its mechanism of action is partially understood, and efficacy is variable. OBJECTIVE: To conduct an exploratory analysis of brain networks connectivity changes on resting state (RS) functional MRI (fMRI) of MS patients treated with nabiximols. METHODS: We identified a group of MS patients treated with Sativex® at Verona University Hospital, who underwent RS brain fMRI in the 4 weeks before (T0) and 4-8 weeks after (T1) treatment start...

Non-prescription cannabidiol (CBD) and medical marijuana (cannabis) currently do not have US Food and Drug Administration (FDA)-approved prescribing information nor a dedicated resource to evaluate potential cannabinoid drug-drug interactions with other medications. The CANNabinoid Drug Interaction Review (CANN-DIR™) is a free web-based platform that has been developed to screen for potential drug-drug interactions from the perspective of how a cannabinoid delta-9-tetrahydrocannabinol (THC), CBD, or a combination of THC/CBD may affect the metabolism of another prescribed medication...

BACKGROUND: In this review, we provide an updated assessment of available evidence on the pharmacokinetics (PK) of cannabidiol (CBD) and explore the impact of different factors on PK outcomes. MATERIALS AND METHODS: This systematic review and meta-regression analysis was pre-registered (PROSPERO: CRD42021269857). We systematically searched Medline, Embase, PsychInfo, and Web of Science Core Collection up to November 19, 2022. Trials of CBD in healthy adults were included if they reported at least one of the PK parameters of interest, including Tmax, Cmax, AUC0-t, AUC0-inf, and T 1/2 , in serum or plasma...

PURPOSE: Previous studies have shown that tetrahydrocannabinol (THC), the main psychoactive component of cannabis, can impair cognitive abilities. There is also some evidence that cannabidiol (CBD), the most abundant non-intoxicating constituent of cannabis, can attenuate these effects. The purpose of this study was to investigate the effects of THC:CBD oromucosal spray (with equal parts THC and CBD) on cognition compared with control conditions in human studies. METHODS: A systematic literature search was performed on four major bibliographic databases...

The analgesic potential of Cannabis sativa L.-based medicinal cannabis products for treatment of cancer associated chronic pains has gained increased interest in recent years. To ensure a controlled distribution of these products and investigate their therapeutic potential, several countries have established so-called pilot trials. Many doctors, however, are hesitant to prescribe medicinal cannabis primarily due to lack of research evidence regarding the products' efficacy, safety and thus questionable dosing guidelines...