Long-Term Data of Efficacy, Safety and Tolerability in a Real Life Setting of THC/CBD Oromucosal Spray-Treated Multiple Sclerosis Patients.
J Clin Pharmacol. 2015 Nov 26. Epub 2015 Nov 26. PMID: 26608223
Delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray was approved as add-on therapy for spasticity in patients with Multiple Sclerosis (MS). We showed our forty-weeks post-marketing 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 four 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<0.0001). Thirty-seven patients (36.2%) discontinued the treatment. The incidence of Adverse Events (AEs) was of 40.2%. Fifty-eight patients (56.9%) were also assessed using the NRS for pain, and 46 patients (45.1%) with bladder dysfunctions were assessed for the IPSS (International Prostatic Symptoms Score) score, showing a significant improvement in these scales (p = 0.011 and p = 0.001 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. This article is protected by copyright. All rights reserved.