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Neurodegener Dis Manag. 2015;5(6 Suppl):19-21. doi: 10.2217/nmt.15.66.

Advances in the management of MS symptoms: real-life evidence.

Author information

1
Department of Basic Clinical Sciences, Neurosciences and Sense Organs, University of Bari, Italy, Policlinico di Bari, Piazza Giulio Cesare, 11 Zip-code 70124, Bari, Italy.

Abstract

Once the efficacy and tolerability of a new intervention have been demonstrated in clinical trials under ideal experimental conditions, observational studies within approved label conditions are performed to determine its effectiveness in real-world use and expand the safety/tolerability data. Several large observational studies have been conducted of Sativex(®) (THC:CBD) oromucosal spray as add-on therapy for moderate-to-severe treatment-resistant multiple sclerosis (MS) spasticity. Studies performed to date with a focus on tolerability have confirmed the absence of abuse, misuse, addiction and lack of impairment of cognition or driving ability. Open-label studies performed to date with a focus on effectiveness have indicated that about one-half to two-thirds of patients initiated on THC:CBD oromucosal spray continue to derive benefit after 3 months' treatment at a mean dosage of 5-7 sprays/day.

KEYWORDS:

Sativex; THC:CBD oromucosal spray; effectiveness; multiple sclerosis; observational studies; review; safety; spasticity

PMID:
26611267
DOI:
10.2217/nmt.15.66
[Indexed for MEDLINE]

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