Cannabis for spasticity

Paolicelli D, Direnzo V, Manni A, D’Onghia M, Tortorella C, Zoccolella S, Lecce VD, Iaffaldano A, Trojano M. 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. doi: 10.1002/jcph.670.

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 is another study that shows that cannabis can have some benefit for people with MS, however it also shows that there is room for improvement, because of side-effect, this is one of the reasons for developing new treatments. Our new treatment works by a new mechanism unrelated to cannabis system. This will be revealed soon.

CoI: We are developing an alternative to cannabis. If you fit the criteria recruitment is ongoing in London (CLICK)

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  • Side effects? Could the safety profile is even comparable with other DMTs? I have another question, for some drugs they use this split between responding / not responding patient (only THC based so fat). This is a sign of efficacy meaning that for responding people the treatment is WORKING well. Why? And Is it the case for a classic DMT with its reduction in relapse rate?

    Let me give an example to clarify this question. I want to know if I understand the difference between 50% responding people and 50% reduction in relapse rate. In the later case, everybody are going to have relapses but 50% less (kind of socialist); in the former case, half of the people have no relapses anymore and half of people have a normal rate of relapses (capitalist but for once I prefer this drug). Do I understand correctly?

    If I am right, It seems like an intellectual dishonesty to highlight only the second measure and not the first, so please tell I am wrong. What is the frequency of respondent people to classic DMTs?

  • Wait a minute. Sativex might not be only useful for spasticity but also for bladder symptoms? Below is the description in their method of the IPSS (International Prostatic Symptoms Score).

    "8 questions screening tool originally used to track and suggest management of the symptoms of
    benign prostatic hyperplasia. The 7 symptoms questions include the feeling of incomplete
    bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia,
    each referring to the last month, and each involving assignment of a score from 1 to 5 for a
    maximum total of 35 points. The 8th question about QoL is assigned a score of 1 to 6; the
    total score is “mild” if between 1 and 7, “moderate” between 8 and 19 and “severe” between
    20 and 35."

    For this score, lower is better like the EDSS. In this study 46 patients had bladder problems. Their mean IPSS score went from 15 to 10 (+ or – 8 in both case). Significant. Don't you think it deserves more investigation?

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