Presented at the 2012 AAPM Annual Meeting « Back

Evaluation of Fentanyl Buccal Soluble Film in Opioid Tolerant Cancer Patients with Neuropathic Breakthrough Cancer Pain

Larry N. Gever, PharmD, wkhps09-lgever@yahoo.com¹, Karen J. Stanley, MSN RN AOCN FAAN², (1) Meda Pharmaceuticals, Somerset, New Jersey, (2) Oncology Nursing Society, Wilton, Connecticut

Neuropathic breakthrough cancer pain (BTP) is poorly understood and difficult to control. Anticonvulsants, antidepressants, alpha-2 adrenergic agonists and NMDA receptor antagonists in combination with opioids are used as treatments. Fentanyl buccal soluble film (FBSF) is approved for the management of BTP in opioid-tolerant cancer patients aged =18 years. The safety and efficacy of FBSF was studied in a multicenter, randomized, double-blind, placebo-controlled, multiple-crossover study in adult cancer patients on stable opioid therapy who reported =4 BTP episodes daily. The study protocols were approved by IRBs and patients provided informed consent. A subgroup of patients was analyzed to evaluate the efficacy and safety of FBSF in patients with neuropathic BTP pain. The primary variable evaluated was the sum of pain intensity differences (SPID) at 30 minutes with higher scores correlating with greater pain relief. Adverse events were recorded and summarized. Fourteen females and nine males (mean age ~51 years) were included in the subgroup analysis. Breast cancer (n = 6) was the most prevalent cancer type. Pain reduction after FBSF treatment was greater than after treatment with placebo. SPID values in patients with neuropathic BTP were significantly higher for FBSF-treated episodes than for those episodes treated with placebo beginning 15 minutes after dosing. FBSF was as effective in this subgroup as in the entire population. The most commonly reported adverse events included somnolence, nausea, and dizziness. The results of this subgroup analysis indicate that FBSF may aid in the management of neuropathic BTP in cancer patients.

Funding: Meda Pharmaceuticals, Somerset, NJ