cannabidiol and tizanidine

Many people with MS (pwMS) use unregulated cannabis or cannabis products to treat the symptoms associated with the disease. In line with this, Sativex, a synthetic combination of cannabidiol (CBD) and Δ

Topics: Analgesics; Animals; Anti-Inflammatory Agents; Baclofen; Cannabidiol; Clinical Trials as Topic; Clonidine; Dose-Response Relationship, Drug; Double-Blind Method; Dronabinol; Drug Approval; Drug Combinations; Drug Therapy, Combination; Female; Humans; Male; Multiple Sclerosis; Spinal Cord; Treatment Outcome; United States; United States Food and Drug Administration

Treatment of spasticity poses a major challenge given the complex clinical presentation and variable efficacy and safety profiles of available drugs. We present a systematic review of the pharmacological treatment of spasticity in multiple sclerosis (MS) patients.. Controlled trials and observational studies were identified. Scientific evidence was evaluated according to pre-specified levels of certainty.. The evidence supports the use of baclofen, tizanidine and gabapentin as first-line options. Diazepam or dantrolene could be considered if no clinical improvement is seen with the previous drugs. Nabiximols has a positive effect when used as add-on therapy in patients with poor response and/or tolerance to first-line oral treatments. Despite limited evidence, intrathecal baclofen and intrathecal phenol show a positive effect in severe spasticity and suboptimal response to oral drugs.. The available studies on spasticity treatment offer some insight to guide clinical practice but are of variable methodological quality. Large, well-designed trials are needed to confirm the effectiveness of antispasticity agents and to produce evidence-based treatment algorithms.

Topics: Amines; Analgesics; Baclofen; Cannabidiol; Clonidine; Cyclohexanecarboxylic Acids; Dantrolene; Diazepam; Dronabinol; Drug Combinations; Excitatory Amino Acid Antagonists; Gabapentin; gamma-Aminobutyric Acid; Humans; Injections, Spinal; Multiple Sclerosis; Muscle Relaxants, Central; Muscle Spasticity; Phenol

Sativex® (THC:CBD oromucosal spray) is indicated as add-on treatment for patients with moderate to severe multiple sclerosis (MS) spasticity. We aimed to determine whether antispasticity treatment history influenced the efficacy and safety of add-on THC:CBD oromucosal spray in MS spasticity patients.. Post hoc analysis of an enriched-design clinical trial of THC:CBD oromucosal spray versus placebo, using records of patients under previous and current ineffective antispasticity therapies. Subgroups were patients with at least 1 failed therapy attempt with either baclofen or tizanidine (Group 1) or at least 2 failed therapy attempts with both baclofen and tizanidine (Group 2).. Of 241 patients in the intent-to-treat population, 162 and 57 patients met the criteria for Groups 1 and 2, respectively. In all groups, response on the spasticity 0-10 Numerical Rating Scale was significantly greater with THC:CBD oromucosal spray versus placebo, for minimal clinically important difference (MCID ≥18% improvement vs. baseline) and clinically important difference (CID, ≥30% improvement vs. baseline). THC:CBD oromucosal spray improved spasticity-related symptoms such as sleep quality and timed 10-meter walk independent of the number of prior failed therapy attempts. Tolerability was not influenced by pre-treatment history.. THC:CBD oromucosal spray provided consistent relief with good tolerability in MS spasticity patients irrespective of their antispasticity pre-treatment history.

Topics: Adult; Baclofen; Cannabidiol; Clonidine; Dronabinol; Drug Combinations; Female; Humans; Male; Middle Aged; Multiple Sclerosis; Muscle Spasticity; Parasympatholytics; Plant Extracts