ECTRIMS eLearning

The use of medical-grade Cannabis (Bedrocan®) in patients non-responders to nabiximols (sativex®)
Author(s): ,
F Saccà
Affiliations:
Department of Neuroscience, Reproductive, and Odontostomatological Sciences, Federico II University
,
C Pane
Affiliations:
Department of Neuroscience, Reproductive, and Odontostomatological Sciences, Federico II University
,
A Carotenuto
Affiliations:
Department of Neuroscience, Reproductive, and Odontostomatological Sciences, Federico II University
,
M Massarelli
Affiliations:
Department of Neuroscience, Reproductive, and Odontostomatological Sciences, Federico II University
,
R Lanzillo
Affiliations:
Department of Neuroscience, Reproductive, and Odontostomatological Sciences, Federico II University
,
E.B Florio
Affiliations:
Farmacia Florio Dr. Ettore SNC, Napoli, Italy
V Brescia Morra
Affiliations:
Department of Neuroscience, Reproductive, and Odontostomatological Sciences, Federico II University
ECTRIMS Learn. Saccà F. 09/16/16; 145978; P1296
Dr. Francesco Saccà
Dr. Francesco Saccà
Contributions
Abstract

Abstract: P1296

Type: Poster

Abstract Category: Therapy - symptomatic - Treatment of specific symptoms

Introduction: Spasticity is one of the most common symptoms in Multiple sclerosis (MS). It causes disability, and is chronically present. Historical treatment includes several drugs with very limited patient and physician satisfaction. Nabiximols (Sativex®) is a cannabis extract containing a 1:1 ratio of delta-9-tetrahydrocannabinol to Cannabidiol. Several studies showed its superiority over placebo in reducing the Numeric Rating Scale (NRS). Unfortunately, half of treated patients do not respond to Nabiximols and for them therapeutic options are absent.

Methods: We retrospectively enrolled patients that had been treated with Nabiximols (Sativex®) for 28 days and were judged non-responders (reduction < 20% from baseline NRS), and were subsequently treated with medical-grade cannabis (Bedrocan®) for at least 28 days. Bedrocan was fractionized at authorized ISO 9001:2008 pharmacies into 50 mg sachets. Patients were instructed to take Bedrocan at a dose of 50-100 mg /day.

Results: We found 13 patients (Table 1) corresponding to our inclusion criteria. Non-response to Nabiximols was caused by insufficient NRS reduction for all patients. Bedrocan was administered orally to eleven patients, and through smoking for two. Mean NRS for Nabiximols Baseline was 7.6±1.5 and 7.4±1.6 after 28 days (-0.2; CI -0.65, +0.15; p=0.493). Mean NRS for Bedrocan baseline was 7.6±1.8 and 5.3±2.4 after 28 days (-2.3; CI -3.58, -1.12; p< 0.001). Patients continued Bedrocan administration for 205±182 days (range 46-700). Two patients suspended therapy, one for the onset of dizziness, and the other for the drug"s cost. Mean NRS at follow-up was 5.6±2.3, resulting in a significant reduction as compared to baseline (-2.0; CI -.2.9, -1.2; p< 0.001). During Bedrocan therapy, only 3 AEs were reported in three patients, as compared to 15 AEs in 11 patients during Nabiximols treatment (Odds Ratio 5.0; CI 1.45, 17.27; p< 0.02).

Discussion: This is the first study that investigates rescue strategies for Nabiximols non-responders. Bedrocan was very well tolerated with 85% responders at 28 days and 70% at the end of the individual follow-up. This is a high response rate if compared to previous trials. Future randomized, placebo-controlled studies are necessary to conclude, at a higher class of evidence, that medicinal-grade cannabis is a good option for Nabiximols non-responders.

Disclosure: Francesco Saccà received personal compensation from Novartis, Almirall, Genzyme, Forward Pharma, and TEVA for public speaking, editorial work and advisory boards; Chiara Pane has nothing to disclose; Antonio Carotenuto has nothing to disclose; Marco Massarelli has nothing to disclose; Roberta Lanzillo received personal compensation from Novartis, Almirall, Genzyme, Merk Serono, Biogen, and TEVA for public speaking, editorial work and advisory boards; Ettore Brunello Florio has nothing to disclose; Vincenzo Bresciamorra received compensation for public speaking, and advisory boards from Biogen, Merk Serono, Bayer, Genzyme, Almirall, Novartis, and TEVA.

Abstract: P1296

Type: Poster

Abstract Category: Therapy - symptomatic - Treatment of specific symptoms

Introduction: Spasticity is one of the most common symptoms in Multiple sclerosis (MS). It causes disability, and is chronically present. Historical treatment includes several drugs with very limited patient and physician satisfaction. Nabiximols (Sativex®) is a cannabis extract containing a 1:1 ratio of delta-9-tetrahydrocannabinol to Cannabidiol. Several studies showed its superiority over placebo in reducing the Numeric Rating Scale (NRS). Unfortunately, half of treated patients do not respond to Nabiximols and for them therapeutic options are absent.

Methods: We retrospectively enrolled patients that had been treated with Nabiximols (Sativex®) for 28 days and were judged non-responders (reduction < 20% from baseline NRS), and were subsequently treated with medical-grade cannabis (Bedrocan®) for at least 28 days. Bedrocan was fractionized at authorized ISO 9001:2008 pharmacies into 50 mg sachets. Patients were instructed to take Bedrocan at a dose of 50-100 mg /day.

Results: We found 13 patients (Table 1) corresponding to our inclusion criteria. Non-response to Nabiximols was caused by insufficient NRS reduction for all patients. Bedrocan was administered orally to eleven patients, and through smoking for two. Mean NRS for Nabiximols Baseline was 7.6±1.5 and 7.4±1.6 after 28 days (-0.2; CI -0.65, +0.15; p=0.493). Mean NRS for Bedrocan baseline was 7.6±1.8 and 5.3±2.4 after 28 days (-2.3; CI -3.58, -1.12; p< 0.001). Patients continued Bedrocan administration for 205±182 days (range 46-700). Two patients suspended therapy, one for the onset of dizziness, and the other for the drug"s cost. Mean NRS at follow-up was 5.6±2.3, resulting in a significant reduction as compared to baseline (-2.0; CI -.2.9, -1.2; p< 0.001). During Bedrocan therapy, only 3 AEs were reported in three patients, as compared to 15 AEs in 11 patients during Nabiximols treatment (Odds Ratio 5.0; CI 1.45, 17.27; p< 0.02).

Discussion: This is the first study that investigates rescue strategies for Nabiximols non-responders. Bedrocan was very well tolerated with 85% responders at 28 days and 70% at the end of the individual follow-up. This is a high response rate if compared to previous trials. Future randomized, placebo-controlled studies are necessary to conclude, at a higher class of evidence, that medicinal-grade cannabis is a good option for Nabiximols non-responders.

Disclosure: Francesco Saccà received personal compensation from Novartis, Almirall, Genzyme, Forward Pharma, and TEVA for public speaking, editorial work and advisory boards; Chiara Pane has nothing to disclose; Antonio Carotenuto has nothing to disclose; Marco Massarelli has nothing to disclose; Roberta Lanzillo received personal compensation from Novartis, Almirall, Genzyme, Merk Serono, Biogen, and TEVA for public speaking, editorial work and advisory boards; Ettore Brunello Florio has nothing to disclose; Vincenzo Bresciamorra received compensation for public speaking, and advisory boards from Biogen, Merk Serono, Bayer, Genzyme, Almirall, Novartis, and TEVA.

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