Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients

Inclusion Criteria:

* The patient is willing to provide written informed consent to participate in this study.
* The patient can be either an out-patient or an in-patient.
* The patient has a histologically documented diagnosis of cancer.
* The patient has stable background pain due to cancer.
* The patient experiences up to 4 BTcP episodes per 24 hours.
* As maintenance opioid therapy, the patient is currently taking 1 of the following: at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone/day, at least 8 mg of hydromorphone/day, of an equianalgesic dose of another opioid for a week or longer before administration of the first dose of study drug.
* Women of childbearing potential, using a medically accepted, highly effective method of birth control and agree to continued use of this method for the duration of the study.
* The patient must be willing and able to successfully self-administer the study drug and to fill in study documents.

Exclusion Criteria:

* The patient is without maintenance opioid therapy.
* The patient has uncontrolled or rapidly escalating pain as determined by the investigator.
* The patient has known or suspected hypersensitivities, allergies, or other contraindications to the active drug or to any of the excipients of the study drug.
* The patient has respiratory depression or chronic obstructive pulmonary disease, or any other medical condition predisposing to respiratory depression.
* 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.
* The patient is pregnant or lactating.
* The patient has participated in a study involving an investigational drug in the prior 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 (e.g., 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.