Tetrahydrocannabinol: Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice

Background: Tetrahydrocannabinol: cannabidiol (THC:CBD) oromucosal spray (Sativex((R))) is an add-on therapy for moderate-to-severe multiple sclerosis (MS)-related drug-resistant spasticity (MSS). Aim: The MOVE-2 EU study collected data from everyday clinical practice concerning the effectiveness and tolerability of THC: CBD. Methods: This was an observational, prospective, multicentre, non-interventional study. Patients with resistant MSS prescribed add-on THC: CBD oromucosal spray according to approved labelling, were followed for 3 months. After 1 month, only responders (>= 20% improvement in spasticity) continued treatment. The main endpoints were the evolution of MSS and associated symptoms, quality of life (QoL) and tolerability. Results: Four hundred and thirty three patients (55% female) were recruited (98% in Italy). The mean duration of MSS was 7.4 years and baclofen was used by 78.1% of participants. Three hundred and forty nine participants continued with THC: CBD oromucosal spray after 1 month, and 281 after 3 months. THC: CBD mean dosage was 6 sprays/day. MSS scores and spasticity-related symptoms (spasms, fatigue, pain, sleep quality and bladder dysfunction) were significantly improved by THC:CBD at 3 months, as were activities of daily living, and QoL (EQ-5D VAS). Adverse events, none of which were severe or serious, were reported by 10.4% of patients. Conclusions: In everyday clinical practice, THC: CBD oromucosal spray provided symptomatic relief of MSS and related troublesome symptoms.