A Randomized, Open, Parallel Group, Multicenter Trial to Investigate Analgesic Efficacy and Safety of a New Transdermal Fentanyl Patch Compared to Standard Opioid Treatment in Cancer Pain

Abstract

A new 72-hour transdermal fentanyl matrix patch has been designed, which has a 35%-50% reduction of the absolute fentanyl content compared with other currently available transdermal fentanyl patches that are using the matrix technology. The new patch has previously been shown to be pharmacokinetically bioequivalent to the marketed fentanyl patch. To determine noninferiority in efficacy in cancer patients and to compare safety, a clinical trial comparing the new fentanyl patch with standard oral or transdermal opioid treatment was planned. The design was an open, parallel group, multicenter trial, in which 220 patients were randomized to receive either the fentanyl patch or standard opioid treatment for 30 days. The primary efficacy variable, pain intensity (PI) on a 0-10-point numerical rating scale, was recorded once daily. The primary endpoint was the relative area under the curve of PI expressed as a percentage of the maximum possible PI area under the curve. Any adverse events were recorded; four tolerability endpoints, constipation, nausea, daytime drowsiness, and sleeping disturbances, were assessed daily. Noninferiority was shown; the upper 95% confidence interval limits of the mean difference in relative PI area under the curve between the fentanyl patch and standard opioid treatment were less than 10% for both the intention-to-treat and per-protocol populations. Scores for the tolerability endpoints were similar in the treatment groups. The new fentanyl matrix patch with a lower drug load was found noninferior and as safe as established standard oral and transdermal opioid treatment.

The Role of Fentanyl in Cancer-Related Pain

“…The newer style patch appears to be pharmacokinetically bioequivalent to the marketed fentanyl patch. 22 Another new administration method is iontophoresis through a battery-operated, patient-controlled transdermal system (PTCS); this process drives medication deep into the dermis with a weak electrical current. 23 The pharmacokinetic properties of the PCTS are similar to those of intravenous fentanyl infusion and appear to be unaffected by gender, age, race, or weight.…”

Multicenter clinical study for evaluation of efficacy and safety of transdermal fentanyl matrix patch in treatment of moderate to severe cancer pain in 474 Chinese cancer patients

“…For the reason that most patients in this study suffered from chronic visceral pain and/or bone pain but not neuropathic origin [2,31] Many studies demonstrated that one of the advantages of TDF was significantly lower incidence of AEs especially constipation compared to other oral opioids used for pain control, while some others reported the equal incidence , analgesic effect was remarkable. [32] Respiratory depression is the most serious and potentially life-threatening adverse effect. In the postmarketing experience, deaths from hypoventilation due to inappropriate use of TDF have been reported.…”

The Use of Transdermal Therapeutic Systems in Psychiatric Care: A Primer on Patches

“…36 Studies indicate that fentanyl patches are effective when compared to the standard forms of opioid management for both acute and chronic pain (e.g., in palliative care and with cancer pain). 18,37 Several studies have found a reduction in certain side effects (including constipation, opioid-associated pruritus, and sedation) in those receiving fentanyl patches compared to other standard pain therapies (e.g., use of extended-release oral morphine). 18,38 Fentanyl is relatively contraindicated in opioid-naïve patients, those with known or suspected paralytic ileus, or those with a history of significant respiratory disease (e.g., severe bronchial asthma, severe chronic obstructive pulmonary disease, cor pulmonale, hypercapnia).…”