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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. 2016 07; 56(7):845-51.JC

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+Show Affiliations

Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro,", Bari, Italy.Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro,", Bari, Italy.Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro,", Bari, Italy.Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro,", Bari, Italy.Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro,", Bari, Italy.Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro,", Bari, Italy.Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro,", Bari, Italy.Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro,", Bari, Italy.Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro,", Bari, Italy.

Pub Type(s)

Journal Article
Observational Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26608223

Citation

Paolicelli, Damiano, et al. "Long-Term Data of Efficacy, Safety, and Tolerability in a Real-Life Setting of THC/CBD Oromucosal Spray-Treated Multiple Sclerosis Patients." Journal of Clinical Pharmacology, vol. 56, no. 7, 2016, pp. 845-51.
Paolicelli D, Direnzo V, Manni A, et al. 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. 2016;56(7):845-51.
Paolicelli, D., Direnzo, V., Manni, A., D'Onghia, M., Tortorella, C., Zoccolella, S., Di Lecce, V., Iaffaldano, A., & Trojano, M. (2016). Long-Term Data of Efficacy, Safety, and Tolerability in a Real-Life Setting of THC/CBD Oromucosal Spray-Treated Multiple Sclerosis Patients. Journal of Clinical Pharmacology, 56(7), 845-51. https://doi.org/10.1002/jcph.670
Paolicelli D, et al. 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. 2016;56(7):845-51. PubMed PMID: 26608223.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-Term Data of Efficacy, Safety, and Tolerability in a Real-Life Setting of THC/CBD Oromucosal Spray-Treated Multiple Sclerosis Patients. AU - Paolicelli,Damiano, AU - Direnzo,Vita, AU - Manni,Alessia, AU - D'Onghia,Mariangela, AU - Tortorella,Carla, AU - Zoccolella,Stefano, AU - Di Lecce,Valentina, AU - Iaffaldano,Antonio, AU - Trojano,Maria, Y1 - 2015/12/30/ PY - 2015/09/02/received PY - 2015/10/29/accepted PY - 2015/11/27/entrez PY - 2015/11/27/pubmed PY - 2017/8/16/medline KW - THC/CBD KW - bladder dysfunction KW - multiple sclerosis KW - pain KW - spasticity SP - 845 EP - 51 JF - Journal of clinical pharmacology JO - J Clin Pharmacol VL - 56 IS - 7 N2 - 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. SN - 1552-4604 UR - https://www.unboundmedicine.com/medline/citation/26608223/Long_Term_Data_of_Efficacy_Safety_and_Tolerability_in_a_Real_Life_Setting_of_THC/CBD_Oromucosal_Spray_Treated_Multiple_Sclerosis_Patients_ L2 - https://doi.org/10.1002/jcph.670 DB - PRIME DP - Unbound Medicine ER -