MILAN—Breakthrough pain in cancer patients can be managed easily and effectively with fentanyl pectin nasal spray (FPNS), according to new data.
FPNS can be easily titrated to an effective dose and there is little need for rescue medication, according to David Brooks, MD, of Chesterfield and North Derbyshire Royal Hospital NHS Trust in Chesterfield, United Kingdom.
“This study shows that if you put in the effort, you can titrate this drug to the right dose in the majority of patients, and they will stick with the treatment and achieve successful pain control,” Brooks said.
The study’s first author was Luis Torres, MD, of the Servicio de Anestesia-Reanimacion y Tratamiento del Dolor, Hospital Puerta del Mar in Cadiz, Spain.
Typically, breakthrough pain has a rapid onset and is severe to excruciating in intensity, although the pain’s duration is relatively short, he said. Currently, immediate-release morphine is still the mainstay of treatment but takes at least 30 minutes for maximum effect. “Its onset is too slow for the appropriate management of breakthrough pain,” Brooks noted. Intranasal drug delivery is a simple and acceptable means of administering strong analgesics, and has rapid absorption, he said.
Brooks reported on an analysis of the open-label dose-titration outcomes in the FPNS phase 3 clinical trial program involving 500 cancer patients with breakthrough pain. The program consisted of three studies, which found that there was rapid onset of efficacy and significant pain relief for FPNS versus placebo. The current analysis of the program evaluated FPNS’s ease of titration, speed of relief, and reliability.
Of the 500 patients, 401 (80.2%) were successfully titrated and continued through their treatments. Overall, they were successfully titrated to the following dosages: 100 μg (17.7%), 200 μg (12.8%), 400 μg (32.0%), and 800 μg (28.5%).
FPNS required an average of only 2.7 steps for titration across the three studies, Brooks reported. Successful dose titration did not vary by age or weight. Success rates were consistent across the three multinational trials that involved 13 countries, the authors reported.
Only 8% of patients could not be successfully titrated because of an FPNSrelated reason, most commonly an adverse event or inadequate efficacy at the highest dose. Treatment-related adverse events included headache, nausea, and vomiting, which were consistent with the pharmacologic effects of fentanyl.
Only 6% of FPNS-treated episodes required additional rescue medication within 60 minutes, and only 10% required an increase in dose for FPNS to maintain its efficacy. Of the 205 patients who completed the open-label treatment phase, 71% elected to continue treatment with FPNS in the ensuing extension period, Brooks noted.
“I see this agent used not just for breakthrough pain but to preempt pain before it occurs, such as when patients get out of bed to go to the toilet,” he added. “As a preemptive analgesic it might allow for more activity.”
This study was sponsored by Archimedes Pharma, which manufactures PecFent