Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Non-Malignant Pain
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Non-Malignant Pain
The purpose of this study is to evaluate the safety of the matrix fentanyl patch ZR-02-01 in
 providing relief of non-malignant chronic pain.
This study will evaluate the safety of the matrix fentanyl patch. The study will be conducted
 in opioid-tolerant patients with moderate to severe non-malignant chronic pain currently
 taking an around-the-clock opioid. Patients will discontinue their current opioid regimen and
 begin using ZR-02-01 as soon as possible under the direction of the physician investigator
 upon entry into the study. Patient's dose of ZR 02 01 will be determined by the investigator
 using sponsor-provided conversion. Pain therapy will be under the supervision of the
 physician investigator.
Inclusion Criteria:

 -  Patient is at least 18 and no older than 75 years of age

 -  Patient has moderate to severe, non-malignant chronic pain that is expected to last
 for at least 12 months and is currently taking an around-the-clock opioid to treat
 his/her pain

 -  Patient is already receiving opioid therapy, has demonstrated opioid tolerance, and
 requires a total daily dose of opioids at least equivalent to 25 mcg/hr of transdermal
 fentanyl. Patients who are considered opioid-tolerant are those who have been taking a
 daily dose of at least 30 mg of oral morphine or morphine equivalent opioid for at
 least 2 weeks.

 Exclusion Criteria:

 -  Patient has active cancer

 -  Patient has a history of substance abuse or has a substance abuse disorder