- Chronic moderate to severe non-cancer pain that has been treated with opioid
analgesics for at least three months (with stabilized pain control and stabilized dose
for 28 days prior to enrollment).
- Receiving an opioid dose equivalent to 20 mg - 120 mg morphine once or twice daily.
- Patient displays signs and symptoms of withdrawal (i.e., COWS score ≥5) following
naloxone administration during the Naloxone Challenge.
If female and able to become pregnant, must use an approved method of birth control.
- Excluding the chronic moderate to severe non-cancer pain, the patient is judged by the
Investigator to be in generally good health at screening based upon the results of a
medical history, physical examination, laboratory profile, and 12 lead
electrocardiogram (ECG).
- Female who is pregnant or breastfeeding.
- Patient has a known allergy or history of significant adverse reaction to morphine,
other opioids, naltrexone, acetaminophen, or related compounds.
- Patient is receiving systemic chemotherapy, has an active malignancy of any type, or
has been diagnosed with cancer within the 5 years prior to screening (excluding
squamous or basal cell carcinoma of the skin).
- History of, or ongoing, alcohol or drug abuse.
- Patient has made a donation of blood or has had a significant blood loss within 30
days prior to screening.