A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Evaluate the Safety and Efficacy of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
- Opioid-tolerant, defined as undergoing opioid treatment for cancer-related pain for ≥
7 days and meeting 1 of the following criteria:
- Receiving at least 60 mg of oral morphine/day
- Receiving at least 25 mcg of transdermal fentanyl/hour
- Receiving at least 30 mg of oxycodone/day
- Receiving at least 8 mg of oral hydromorphone/day
- Receiving an equianalgesic dose of another opioid
- Experiences persistent pain related to the cancer or its treatment of moderate or
lesser intensity in the 24 hours prior to assessment by a verbal rating scale at the
screening visit
- Experiences on average one to four breakthrough cancer pain episodes per day usually
at least partially controlled by supplemental medication of at least 5 mg
immediate-release morphine or an equivalent short-acting opioid (e.g., oxycodone,
hydrocodone, or codeine with acetaminophen)
- Brain metastases allowed provided the patient has no signs or symptoms of increased
intracranial pressure
PATIENT CHARACTERISTICS:
- Able to evaluate pain relief, assess medication performance, convey adverse events,
and record each use of the study drug or supplemental medication in an electronic
diary (a caregiver may provide the patient the medication and help with the
electronic diary but cannot enter information)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No intolerable side effects to opioids or fentanyl
- No history of major organ system impairment or disease, that in the investigator's or
his/her designee's opinion, could increase the risk associated with the use of
opioids
- No uncontrolled hypertension (systolic blood pressure [BP] > 180 mm Hg or diastolic
BP > 90 mm Hg on two occasions at least six hours apart) despite antihypertensive
therapy
- No hypertensive crisis within the past two years
- No recent history (within the past two years) of transient ischemic attacks, neural
vascular disease, stroke, or cerebral aneurysms
- No clinically uncontrolled sleep apnea
- No inability to assess pain or response to pain medications for any reason, including
psychiatric disorder, concurrent medical disorder, or concomitant therapy
- No painful erythema, edema, or ulcers under the tongue
PRIOR CONCURRENT THERAPY:
- At least 30 days since prior investigational study product(s)
- At least 14 days since prior monoamine oxidase inhibitors
- Medications or therapies that have been and continue to be used for a chronic disease
condition may be continued throughout the study provided the medication or therapy is
stable in dose and frequency for at least one week prior to the screening visit
- Medications used to help manage pain (e.g., bisphosphonates, steroids, or gabapentin)
allowed provided the medication is stable in dose and frequency for at least one week
prior to the screening visit of the study and the dose/frequency are not anticipated
to change during the study
- Short-acting commercially available fentanyl medications used to help manage
breakthrough pain (e.g., buccal fentanyl [Fentora®] or transmucosal fentanyl
[Actiq®]) allowed for up to one-week prior to study entry onto the open-label
titration period, but are not allowed during the open-label titration period or
double-blind randomization period of the study
- Patients who complete the double-blind period and final visit of this study are
eligible to proceed to INSYS-INS-06-007