O

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C, complete; O, ongoing; MS, multiple sclerosis; SCI, spinal cord injury; RA, rheumatoid arthritis.

* Randomized, double-blind, placebo-controlled crossover study. Randomized, double-blind, placebo-controlled parallel group study.

* Open-label study.

* Target recruitment figure.

and other formulations/products of GW's portfolio. To date, the results from three pharmacokinetic studies have been published [47-49].

Clinical programme results

Of the 11 efficacy studies completed to date (five phase II; six phase III), all

II have yielded a range of positive results [50-60]. An additional three phase

III trials commenced in 2002 and are due to complete in 2005.

In all studies all patients remained on the best current therapy available for their condition. However, they still had sufficient residual symptom-severity scores for them to seek further treatment (i.e. there was still a high clinical unmet need despite best available therapy). Sativex® was added to all their other medications, which were kept stable during the baseline/run-in periods and throughout the study period. The subsequent improvement in symptoms that was observed following treatment with Sativex® was in addition to any benefit they had previously derived from their existing therapy.

Phase II data

In phase II studies the following effects were seen:

• improvement in bladder-related symptoms [52];

• improvement in sleep, mood and overall sense of well-being [50-52];

• improvement in morning pain in rheumatoid arthritis [54];

• opiate sparing effects

Phase III data

In randomized, double-blind, placebo controlled, phase III studies the following effects were seen:

• relief of central neuropathic pain (CNP) in MS [55] (see Fig. 4);

• relief of CNP in brachial plexus avulsion [56] (see Fig. 5);

• relief of chronic refractory pain of neurological origin [57];

• relief of spasticity in MS [58, 59] (see Figs 6 and 7);

• relief of peripheral neuropathic pain [60];

• relief of relief of sleep disturbance and improvement in sleep quality [55-58, 60] (see Fig. 8);

• improvement in patients quality of life [55, 60].

Figure 4. Relief of central neuropathic pain in MS [55]. BS11, Box Scale 11. Adapted from Rog and Young [55].

Study BP0101 - Diary card pain scores a! week 2

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