By Jill Stein
BOSTON, MA -- May 1, 2007 -- Fentanyl buccal tablet is effective for the management of breakthrough pain in opioid-tolerant patients with chronic neuropathic pain, according to data presented here at the American Academy of Neurology (AAN) 59th Annual Meeting.
"Our study is the first controlled trial of pharmacologic therapy for breakthrough pain associated with chronic neuropathic pain in noncancer patients," said David M. Simpson, MD, professor, division of neurology, Mount Sinai Medical Center, New York, New York.
For the trial, 102 patients identifying an effective fentanyl buccal tablet dose (100-800 mcg) were randomized to 1 of 3 treatment sequences -- 9 breakthrough pain episodes treated with 6 fentanyl and 3 with placebo.
Outcome measures included time-weighted sum of pain intensity differences (SPID; 30, 60, 90, 120 min) derived from pain intensity scores (0 = no pain, 10 = worst pain); total pain relief (TOTPAR; 60, 90, 120 min) derived from pain relief scores (0 = none, 4 = a lot); patient-rated global medication performance (GMP; 0 = poor, 4 = excellent; 60, 90 min); and medication preference (patient questionnaire).
Overall, 75 patients were evaluable for efficacy.
The investigators found that fentanyl was significantly better than placebo (P <.0001) on every measure at every time point:
- SPID: 30, 60, 90, and 120 min: 3.2 versus 2.0; 9.6 versus 5.7; 16.8 versus 10.0; 24.1 versus 14.4;
- TOTPAR: 60, 90, and 120 min: 6.3 versus 3.8; 10.7 versus 6.6; 15.3 versus 9.4;
- GMP: 60 and 90 min: 2.1 versus 1.2; 2.2 versus 1.3.
Most patients preferred fentanyl to their previous breakthrough pain medication and rated it as "good" or "excellent" in terms of onset of action, ease of administration, and convenience of use.
Adverse effects were similar to those typically seen with opioids (except for application site effects) and were mostly observed during the dose-titration period.
Fentanyl buccal tablet is currently indicated for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying chronic, persistent cancer pain.
The study was sponsored by Cephalon, Inc
[Presentation title: Fentanyl Buccal Tablet (FBT) for the Treatment of Breakthrough Pain in Opioid-Tolerant Patients With Neuropathic Pain: Efficacy and Patient Preference Outcomes From a Double-Blind, Placebo-Controlled Study. Abstract P02.111]
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