A Multicenter, Non-comparative, Open-label Extension Study to Assess the Long Term Safety of Sativex® Oromucosal Spray (Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer-related Pain

Inclusion Criteria:

- Patient has completed the parent study within the last seven days

- Willing and able to give written informed consent

- Willing and able to comply with all study requirements

Exclusion Criteria:

- The patient is currently using cannabis or cannabinoid based medications, other than
the parent study IMP, and is unwilling to abstain for the duration of the study

- Any history or immediate family history of schizophrenia, other psychotic illness,
severe personality disorder or other significant psychiatric disorder other than
depression associated with their underlying condition

- Any known or suspected history of a substance abuse/dependence disorder (including
opiate abuse/dependence prior to the diagnosis of cancer)

- Has poorly controlled epilepsy or recurrent seizures (i.e. one or more seizure during
the last year)

- Has experienced myocardial infarction or clinically significant cardiac dysfunction
within the last 12 months or has a cardiac disorder that, in the opinion of the
investigator would put the patient at risk of a clinically significant arrhythmia or
myocardial infarction

- Has significantly impaired renal function

- Has significantly impaired hepatic function

- Female patients of child-bearing potential and male patients whose partner is of
child-bearing potential, unless willing to ensure that they or their partner use
effective contraception, for example, oral contraception, double barrier,
intra-uterine device, during the study and for three months thereafter (however, a
male condom should not be used in conjunction with a female condom as this may not
prove effective)