Efficacy and Safety of Intranasal Fentanyl in the Treatment of Breakthrough Pain (FT-018-IM)

Inclusion criteria

• Has the patient given informed consent according to local requirements before any trial-related activities? Trial-related activities are any procedure that would not have been performed during the routine management of the patient
• Is the patient a cancer patient with breakthrough pain?
• Is the patient aged ≥18 years?
• Has the patient received for at least the past month either oral morphine, oxycodone, hydromorphone or transdermal fentanyl for treatment of background pain?
• Is the current dose of the scheduled background opioid of the patient equivalent to 60-500 mg oral morphine/day or to transdermal fentanyl 25-200 µg/hour? For conversion table.
• Is the background pain generally stable and on average controlled to a mild level (defined as ≤4 on an 11 point NRS) by the background opioid?
• Is the BTP(s) in general of so severe pain intensity that the patient judges he/she needs additional analgesics (apart from background pain analgesics) and does it normally last for more than 15 minutes?
• Does the patient in general while using a stable, fixed-schedule, opioid regimen have at least three BTP episodes per week but no more than four BTP episodes per day?*
• Has the patient obtained at least partial relief of BTP(s) with his/her usual immediate-release strong opioid, i.e. oral morphine, oxycodone, hydromorphone or transmucosal fentanyl?
• Is the patient able to use intranasal drugs?
• Does the patient use adequate contraceptive precaution (contraceptive pill, implant or injection or intrauterine device) in the trial period?
• Did the patient have a negative pregnancy test at the inclusion in studies FT-016-IM or FT-017-IM?

Exclusion criteria

All exclusion criteria must be answered "no" for a patient to participate in the trial.

• Does the patient have a recent history of substance abuse?
• Is the patient pregnant or nursing during the trial period?
• Has the patient neurological or psychiatric impairment that may compromise data collection?
• Has the patient severe hepatic impairment? (Investigator's judgement according to local practice)
• Has the patient had any recent therapy, which could potentially alter pain or response to analgesics to a degree, where the need for background opioid will be less than 60 mg morphine or morphine equivalents/day or less than 25 µg/hour transdermal fentanyl or the number of BTP episodes will be less than three per week during the trial period?
• Has the patient had facial radiotherapy?
• Has the patient been treated with MAO inhibitor within the last 14 days?
• Does the patient use Methadone or Buprenorphine?
• Does the patient have an impaired respiratory function to an extent, which may severely increase the risk of clinically relevant respiratory depression by BTP fentanyl treatment?
• Does the patient use drugs for intranasal administration?
• Does the patient have nasopharyngeal probe?
• Is the patient known to be hypersensitive to fentanyl or to other opioids or any of their excipients?
• Has the patient any head injury, primary brain tumour or other pathological conditions, which could significantly increase the risk of increased intracranial pressure or impaired consciousness?
• Has the patient concomitant participation in any other trial with an investigational drug or device apart from cancer treatment and participation in intranasal fentanyl trials FT-016-IM/ FT-017-IM within 30 days prior to inclusion in this trial?
• Does the patient have pathological conditions of the nasal cavity as contraindication to intranasal fentanyl?