title: Long-Term Data of Efficacy, Safety, and Tolerability in a Real-Life Setting of THC/CBD Oromucosal Spray-Treated Multiple Sclerosis Patients.
abstract: Delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray was approved as add-on therapy for spasticity in patients with multiple sclerosis (MS). We show our 40-week postmarketing experience regarding efficacy and safety of THC/CBD spray in an Italian cohort of 102 MS patients. Patients were evaluated using the Expanded Disability Status Scale (EDSS) score, the Numerical Rating Scale (NRS) for spasticity, the Ambulation Index (AI), and Timed 25-Foot Walk (T25-FW) at the beginning of treatment and then every 3 months. After 4 weeks, if a clinically significant improvement in spasticity (at least 20% of baseline NRS score) was not seen, administration of the drug was stopped. In our cohort, patients received an average of 6.5 ± 1.6 sprays each day. The mean reduction to the NRS spasticity score was 2.5 ± 1.2 points (P < .0001). Thirty-seven patients (36.2%) discontinued the treatment. The incidence of adverse events (AEs) was 40.2%. Fifty-eight patients (56.9%) were also assessed using the NRS for pain, and 46 patients (45.1%) with bladder dysfunction were assessed for the IPSS (International Prostatic Symptoms Score) score, showing a significant improvement in these scales (P = .011 and P = .001, respectively). In conclusion, treatment with THC/CBD spray appears to be a valid answer to some of the unmet needs in MS patients, such as spasticity and other refractory-to-treatment symptoms.
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro,", Bari, Italy.
authors.forename: Damiano
authors.initials: D
authors.lastname: Paolicelli
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro,", Bari, Italy.
authors.forename: Vita
authors.initials: V
authors.lastname: Direnzo
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro,", Bari, Italy.
authors.forename: Alessia
authors.initials: A
authors.lastname: Manni
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro,", Bari, Italy.
authors.forename: Mariangela
authors.initials: M
authors.lastname: D'Onghia
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro,", Bari, Italy.
authors.forename: Carla
authors.initials: C
authors.lastname: Tortorella
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro,", Bari, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Zoccolella
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro,", Bari, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Di Lecce
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro,", Bari, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Iaffaldano
authors.affiliation: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro,", Bari, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Trojano
mesh_terms: D000328:Adult; D000368:Aged; D002185:Cannabidiol / Q000008:administration & dosage*; D015331:Cohort Studies; D013759:Dronabinol / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects* / Q000378:metabolism; D009103:Multiple Sclerosis / Q000175:diagnosis* / Q000188:drug therapy* / Q000453:epidemiology; D009128:Muscle Spasticity / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D058993:Oral Sprays; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D058993:Oral Sprays; D002185:Cannabidiol; D013759:Dronabinol
keywords: THC/CBD; bladder dysfunction; multiple sclerosis; pain; spasticity