3. Umbruch 4.4..2005 - Online Pot

The development of Sativex ® – a natural cannabis-based medicine 255
“Q: What is it like to have MS?
Person with MS: Get somebody to stay awake for 48 hours, make them
drink loads of coffee so they just can’t sleep, put weights on their
ankles, a pack on their back, make them wear two lots of rubber gloves,
the whole thing. Tell them it’s for the rest of their life, because that’s the
most important thing.”
“…Others obtained pain relief or found that the drug (cannabis) simply
helped them to sleep. Sleepless nights caused by spasms and nocturia
can make the extreme fatigue in MS even worse. The importance of a
good night’s sleep cannot be overestimated. It has a major impact on
Quality of Life.”
Long-term data
The majority of patients (>70%) who participated in the GW randomized studies
elected to receive the drug in long-term, open-label extension studies (>750
patients) [63, 64]. Efficacy with respect to a variety of symptoms has been
maintained over an extended period of time (>1 year). To date, more than 200
patients have remained on treatment for more than 1 year, and a significant
number have remained on treatment for more than 2 years (the maximum is
814 days as of November 2003), with no evidence of tolerance developing.
Dosing has remained steady over the same period, and only minimal levels of
intoxication have been reported using a 0–100 mm VAS scale (scores up to a
maximum of approximately 20 upon initial exposure, diminishing over time).
This, coupled with the low number of serious adverse reactions reported,
demonstrates the tolerability of the product.
The effects observed in the randomized clinical studies have been sustained
over the long-term (Fig. 9).
At baseline, patients in the randomized, placebo-controlled phase had the
following NRS scores: brachial plexus injury, 6.8; neuropathic pain in MS,
6.5; peripheral neuropathic pain, 7.2; spinal cord injury (data not available,
study ongoing).
Safety
GW has now generated more than 800 patient-years of exposure to Sativex ®
since the year 2000. By June 2004, more than 200 patients had been exposed
to Sativex ® for at least 1 year.
The most common adverse events reported during clinical studies were generally
non-serious in nature and are mainly due to application site reactions
(oral pain, dry mouth, oral mucosal disorder, tooth discolouration, mouth ulceration,
oral discomfort, application-site pain, dysgeusia) or intoxication-like