Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain

Exclusion Criteria

• •The patient has uncontrolled or rapidly escalating pain as determined by the investigator (i.e., the around-the-clock (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 a recent history (within 5 years) or current evidence of alcohol or other substance abuse.
• •The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in either study drug.
• •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 that will impact the patient's chronic pain and/or BTP.
• •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 FBT.
• •The patient has participated in a study involving an investigational drug in the prior 30 days.
• •The patient is currently using prescription FBT or immediate-release oxycodone for BTP and is unwilling to undergo re-titration.
• •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 could, 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 the chronic pain currently being treated.
• •The patient has a positive urine drug screen (UDS) for an illicit drug or a medication not prescribed for him/her or which is not medically explainable.