Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain
Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain
A multi-center study to evaluate the efficacy of CHADD (Controlled Heat-Assisted Drug
 Delivery) applied over a 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch for the
 treatment of breakthrough pain in adult patients with moderate to severe non-malignant
 chronic pain. The open-label study arm will last up to 12 days. The double-blind arm will
 last up to 15 days. Eligible patients who complete the open-label arm will be allowed to
 enroll in the double-blind study arm.
ZARS Pharma is developing a Matrix Transdermal Fentanyl/CHADD (Controlled Heat-Assisted Drug
 Delivery) Drug Delivery System to be used for the treatment of chronic and breakthrough pain.
 The Matrix Transdermal Fentanyl/CHADD Drug Delivery System has been designed to provide
 long-term delivery of fentanyl for the treatment of chronic pain as well as intermittent
 increases in fentanyl concentrations for the treatment of breakthrough pain. Breakthrough
 pain is defined as a transitory exacerbation of pain that occurs on a background of otherwise
 stable pain in a patient receiving chronic opioid therapy.

 Matrix Transdermal Fentanyl/CHADD Drug Delivery System has 2 components: a matrix transdermal
 fentanyl patch (the ZR-02-01 patch in doses of 25, 50, 75 and 100 mcg/hr) with corresponding
 thin film dressing (ie, overlay) and the CHADD (Controlled Heat-Assisted Drug Delivery).

 The matrix transdermal fentanyl patch provides a continuous delivery of fentanyl over 72
 hours, in a manner similar to Duragesic®. During a breakthrough pain episode, a CHADD unit is
 placed over (adhered to) the matrix transdermal fentanyl patch. The CHADD is a thin
 patch-like chemical heating device that generates a controlled level of heat for
 approximately 15-20 minutes. The application of heat delivers increased amounts of fentanyl
 when applied over the ZR-02-01 matrix transdermal fentanyl patch.
Inclusion Criteria:

 -  Patient is 18 through 70 years of age.

 -  Patient has moderate to severe non-malignant chronic pain.

 -  Patient is opioid-tolerant, requires treatment with chronic opioids and is currently
 taking a dose of 50 mcg/hr transdermal fentanyl for the treatment of chronic pain.
 Patient must have been taking this dose for at least 2 weeks.

 -  Patient must be experiencing 1 to 4 episodes of target breakthrough pain (breakthrough
 pain that is related to the patient's chronic pain condition) a day while taking a
 dose of 50 mcg/hr transdermal fentanyl.

 Exclusion Criteria:

 -  Patient has active cancer.

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

 -  Patient is pregnant or breastfeeding.