Inclusion Criteria:

- Is the patient a cancer patient with BTP?

- Has the patient received either oral opioids or transdermal fentanyl for treatment of
BGP within the last month prior to the screening visit?

- Is the current dose of prescribed opioids (for BGP) equivalent to 60-1000 mg oral
morphine/day?

- Has the patient's BGP for the last 7 days prior to the screening visit been generally
stable, and on average controlled to a mild level (defined as ≤ 4 on the 11-point
NRS)?

- Does the patient (at the time of the screening visit) experience his/her current BTP
episodes to be of such severe pain intensity, that he/she in general needs additional
analgesia (i.e. on top of the background opioid treatment)?

- Has the patient on average for the last 7 days prior to the screening visit had at
least three BTP episodes per week, but no more than four BTP episodes per day?

- Is the patient able to use intranasal drugs?

- Is the life expectancy of the patient at least 3 months from the date of the
screening visit?

Exclusion Criteria:

1. Has the patient had an illicit substance abuse within the last year prior to
screening?

2. Does the patient have severe hepatic impairment? - defined as ALT or AST levels > 3x
ULN

3. Does the patient have severe renal impairment? - defined as serum creatinine ≥ 3.0
mg/dl (265 micromol/L)

4. Has the patient ever had facial radiotherapy or is the patient scheduled to facial
radiotherapy?

5. Has the patient been treated with any MAO inhibitors within the last 14 days prior to
the screening visit?

6. Does the patient have severe impaired respiratory function, which may increase the
risk of clinically relevant respiratory depression by BTP fentanyl treatment?

7. Is the patient known to be hypersensitive to fentanyl or to other opioids or any of
their excipients?

8. Does the patient have any head injury, primary brain tumor or other pathological
conditions, which could significantly increase the risk of increased intracranial
pressure or impaired consciousness?