title: Advances in the management of MS symptoms: real-life evidence.
abstract: Once the efficacy and tolerability of a new intervention have been demonstrated in clinical trials under ideal experimental conditions, observational studies within approved label conditions are performed to determine its effectiveness in real-world use and expand the safety/tolerability data. Several large observational studies have been conducted of Sativex(®) (THC:CBD) oromucosal spray as add-on therapy for moderate-to-severe treatment-resistant multiple sclerosis (MS) spasticity. Studies performed to date with a focus on tolerability have confirmed the absence of abuse, misuse, addiction and lack of impairment of cognition or driving ability. Open-label studies performed to date with a focus on effectiveness have indicated that about one-half to two-thirds of patients initiated on THC:CBD oromucosal spray continue to derive benefit after 3 months' treatment at a mean dosage of 5-7 sprays/day.
authors.affiliation: Department of Basic Clinical Sciences, Neurosciences and Sense Organs, University of Bari, Italy, Policlinico di Bari, Piazza Giulio Cesare, 11 Zip-code 70124, Bari, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Trojano
mesh_terms: D000203:Activities of Daily Living; D002185:Cannabidiol; D019468:Disease Management; D013759:Dronabinol; D004338:Drug Combinations; D006801:Humans; D009103:Multiple Sclerosis / Q000150:complications / Q000628:therapy*; D009128:Muscle Spasticity / Q000188:drug therapy / Q000209:etiology; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use; D011358:Product Surveillance, Postmarketing
chemical_list: D004338:Drug Combinations; D010936:Plant Extracts; D002185:Cannabidiol; D013759:Dronabinol; C587251:nabiximols
keywords: Sativex; THC:CBD oromucosal spray; effectiveness; multiple sclerosis; observational studies; review; safety; spasticity