PMID- 26608223
OWN - NLM
STAT- MEDLINE
DCOM- 20170815
LR  - 20220408
IS  - 1552-4604 (Electronic)
IS  - 0091-2700 (Linking)
VI  - 56
IP  - 7
DP  - 2016 Jul
TI  - Long-Term Data of Efficacy, Safety, and Tolerability in a Real-Life Setting of 
      THC/CBD Oromucosal Spray-Treated Multiple Sclerosis Patients.
PG  - 845-51
LID - 10.1002/jcph.670 [doi]
AB  - 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.
CI  - (c) 2015, The American College of Clinical Pharmacology.
FAU - Paolicelli, Damiano
AU  - Paolicelli D
AD  - Department of Basic Medical Sciences, Neuroscience and Sense Organs, University 
      of Bari "Aldo Moro,", Bari, Italy.
FAU - Direnzo, Vita
AU  - Direnzo V
AD  - Department of Basic Medical Sciences, Neuroscience and Sense Organs, University 
      of Bari "Aldo Moro,", Bari, Italy.
FAU - Manni, Alessia
AU  - Manni A
AD  - Department of Basic Medical Sciences, Neuroscience and Sense Organs, University 
      of Bari "Aldo Moro,", Bari, Italy.
FAU - D'Onghia, Mariangela
AU  - D'Onghia M
AD  - Department of Basic Medical Sciences, Neuroscience and Sense Organs, University 
      of Bari "Aldo Moro,", Bari, Italy.
FAU - Tortorella, Carla
AU  - Tortorella C
AD  - Department of Basic Medical Sciences, Neuroscience and Sense Organs, University 
      of Bari "Aldo Moro,", Bari, Italy.
FAU - Zoccolella, Stefano
AU  - Zoccolella S
AD  - Department of Basic Medical Sciences, Neuroscience and Sense Organs, University 
      of Bari "Aldo Moro,", Bari, Italy.
FAU - Di Lecce, Valentina
AU  - Di Lecce V
AD  - Department of Basic Medical Sciences, Neuroscience and Sense Organs, University 
      of Bari "Aldo Moro,", Bari, Italy.
FAU - Iaffaldano, Antonio
AU  - Iaffaldano A
AD  - Department of Basic Medical Sciences, Neuroscience and Sense Organs, University 
      of Bari "Aldo Moro,", Bari, Italy.
FAU - Trojano, Maria
AU  - Trojano M
AD  - Department of Basic Medical Sciences, Neuroscience and Sense Organs, University 
      of Bari "Aldo Moro,", Bari, Italy.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20151230
PL  - England
TA  - J Clin Pharmacol
JT  - Journal of clinical pharmacology
JID - 0366372
RN  - 0 (Oral Sprays)
RN  - 19GBJ60SN5 (Cannabidiol)
RN  - 7J8897W37S (Dronabinol)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Cannabidiol/*administration & dosage
MH  - Cohort Studies
MH  - Dronabinol/*administration & dosage
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Italy/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Mouth Mucosa/*drug effects/metabolism
MH  - Multiple Sclerosis/*diagnosis/*drug therapy/epidemiology
MH  - Muscle Spasticity/diagnosis/drug therapy/epidemiology
MH  - *Oral Sprays
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - THC/CBD
OT  - bladder dysfunction
OT  - multiple sclerosis
OT  - pain
OT  - spasticity
EDAT- 2015/11/27 06:00
MHDA- 2017/08/16 06:00
CRDT- 2015/11/27 06:00
PHST- 2015/09/02 00:00 [received]
PHST- 2015/10/29 00:00 [accepted]
PHST- 2015/11/27 06:00 [entrez]
PHST- 2015/11/27 06:00 [pubmed]
PHST- 2017/08/16 06:00 [medline]
AID - 10.1002/jcph.670 [doi]
PST - ppublish
SO  - J Clin Pharmacol. 2016 Jul;56(7):845-51. doi: 10.1002/jcph.670. Epub 2015 Dec 30.