Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain

Inclusion Criteria: Patients are included in the study if all of the following criteria are met:

• The patient is willing to provide written informed consent to participate in thisstudy.

• The patient is 18 through 80 years of age.

• Women must be surgically sterile, 2 years postmenopausal, or, if of childbearingpotential, using a medically accepted method of birth control (ie, barrier method withspermicide, steroidal contraceptive [oral, transdermal, implanted, and injectedcontraceptives must be used in conjunction with a barrier method], or intrauterinedevice [IUD]) and agree to continued use of this method for the duration of the study.

• The patient has chronic pain of at least 3 months' duration associated with any of thefollowing conditions: diabetic peripheral neuropathy, postherpetic neuralgia,traumatic injury, complex regional pain syndrome, back pain, neck pain, fibromyalgia (documented diagnosis), chronic pancreatitis, or osteoarthritis. Other chronic painfulconditions may be evaluated for entry upon discussion with, and written approval from,the Cephalon Medical Monitor.

• The patient is currently using 1 of the following: at least 60 mg of oralmorphine/day, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg ofoxycodone/day, or at least 8 mg of hydromorphone/day, or an equianalgesic dose ofanother opioid/day as a stable dose of ATC therapy for at least the previous 30 daysprior to enrollment in the study.

• The patient reports an average pain intensity score, over the prior 24 hours, of 6 orless (0=no pain through 10=worst pain) for his/her chronic pain.

• The patient experiences, on average, 1 to 4 BTP episodes (defined as temporary flaresof severe or excruciating pain) per day while taking ATC opioid therapy, and onaverage, the duration of each BTP episode is less than 4 hours.

• The patient currently uses opioid therapy for alleviation of BTP episodes, occurringat the location of the chronic pain, and achieves at least partial relief.

• The patient is able to effectively self-administer the study drug and complete theelectronic diary.

Exclusion Criteria: Patients are excluded from participating in this study if 1 or more of the followingcriteria are met:

• The patient has uncontrolled or rapidly escalating pain as determined by theinvestigator (ie, the ATC therapy may be expected to change between the first and lasttreatments with study drug), or has pain uncontrolled by therapy that could adverselyimpact the safety of the patient or that could be compromised by treatment with studydrug.

• The patient has known or suspected hypersensitivities, allergies, or othercontraindications to any ingredient in the study drug.

• The patient has a recent history (within 5 years) or current evidence of alcohol orother substance abuse.

• The patient has cardiopulmonary disease that would, in the opinion of theinvestigator, significantly increase the risk of treatment with potent syntheticopioids.

• The patient has medical or psychiatric disease that, in the opinion of theinvestigator, would compromise collected data.

• The patient is expected to have surgery during the study and it is anticipated thatthe surgery will alleviate the patient's pain.

• The patient has had therapy before study drug treatment that, in the opinion of theinvestigator, 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 theprevious 30 days.

• The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days beforethe first treatment with study drug.

• The patient has any other medical condition or is receiving concomitantmedication/therapy (eg, regional nerve block) that would, in the opinion of theinvestigator, 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 currentlybeing treated.

• The patient has a positive urine drug screen (UDS) for a medication not prescribed bythe physician currently treating the chronic pain.