Company hopes to launch cannabis medicine in 2004
The
first cannabis-based medicine will be marketed in 2004, GW Pharmaceuticals
hopes, after new data have demonstrated the drug’s efficacy and safety.
Phase I and II trial results showed that cannabis
preparations had clinically significant benefits compared with placebo
in terms of pain, overall symptom relief and sleep duration.
Of 44 patients who completed the study, 41 sustained
sufficient benefit to remain on treatment. Patients were suffering principally
from multiple sclerosis or spinal cord injury.
The trial results also demonstrated that the preparation
was safe and that by self dose-adjustment, most patients were able to
separate the thresholds for symptom relief and intoxication.
The data were presented by GW Pharmaceuticals at
an American Academy of Pain Management meeting in Virginia on 7 September.
Dr Geoffrey Guy, GW Pharmaceutical’s chairman, commented:
“We remain confident of being able to present data on quality, safety
and efficacy to the United Kingdom regulatory authorities in 2003 and,
subject to approval, to bring the first cannabis-based prescription medicine
to market in early 2004.”
The company adds that the Medicines Control Agency
has extended the approved length of time that cannabis-based medicines
can be used from 12 to 24 months.
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