Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain

Exclusion Criteria

• •Patients are excluded from participating in this study if 1 or more of the following criteria are met:
• •The patient has uncontrolled or rapidly escalating pain as determined by the investigator (ie, the ATC therapy may be expected to change between the first and last treatments with study drug), or has pain uncontrolled by therapy that could adversely impact the safety of the patient or that could be compromised by treatment with study drug.
• •The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in the study drug.
• •The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse.
• •The patient has cardiopulmonary disease that would, in the opinion of the investigator, significantly increase the risk of treatment with potent synthetic opioids.
• •The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data.
• •The patient is expected to have surgery during the study and it is anticipated that the surgery will alleviate the patient's pain.
• •The patient has had therapy before study drug treatment that, in the opinion of the investigator, could alter pain or response to pain medication.
• •The patient is pregnant or lactating.
• •The patient has participated in a previous study with ORAVESCENT fentanyl.
• •The patient has participated in a study involving an investigational drug in the previous 30 days.
• •The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug.
• •The patient has any other medical condition or is receiving concomitant medication/therapy (eg, regional nerve block) that would, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise collected data.
• •The patient is involved in active litigation in regard to their chronic pain.
• •The patient has a positive urin screen (UDS) for a medication not prescribed by their physician or no reasonable explanation can be provided to the Cephalon medical monitor.