Fentanyl Buccal Soluble Film May Be Effective for Neuropathic Breakthrough Cancer Pain

AUSTIN, TX—A subgroup analysis presented at the American Pain Society’s 30^th Annual Scientific Meeting demonstrated that fentanyl buccal soluble film is effective in the management of breakthrough neuropathic pain in cancer patients. The mechanisms underlying neuropathic pain are not well understood, making pain management difficult. To achieve effective pain control, drugs not typically used as analgesics (eg, anticonvulsants, antidepressants, alpha-2 adrenergic agonists, and NMDA receptor antagonists) are used in combination with opioids for the treatment of neuropathic pain.

Karen Stanley, RN, MSN, AOCN, FAAN, Stamford Hospital, Stamford, CT, and colleagues, analyzed the efficacy and safety of fentanyl buccal soluble film in a subgroup of patients with neuropathic breakthrough pain in a multicenter, randomized, double-blind, placebo-controlled, multiple-crossover study conducted in adult cancer patients on stable opioid therapy who reported ≤4 breakthrough pain episodes per day. The subgroup analysis included 14 females and nine males (mean age: 51 years); breast cancer (n=6) was the most prevalent type of cancer among these patients. In the open-label titration phase of the main study, patients identified a dose of fentanyl buccal soluble film (ranging from 200mcg-1,200mcg) that adequately controlled their breakthrough pain.

The primary variable evaluated was the sum of pain intensity differences (SPID) at 30 minutes, with higher scores correlating with greater pain relief. Dr. Stanley stated that the results showed pain reduction after treatment to be greater with fentanyl buccal soluble film than with placebo. SPID values in patients with neuropathic breakthrough pain were significantly higher for fentanyl buccal soluble film-treated episodes than for those episodes treated with placebo, beginning 15 minutes after dosing. The most commonly reported adverse events included somnolence, nausea, and dizziness, all of which are commonly associated with opioid use. All five dose strengths were shown to be safe and well tolerated.

Results of the analysis showed that fentanyl buccal soluble film was as effective in this subgroup of patients with neuropathic pain as in the entire population and indicate that fentanyl buccal soluble film may aid in the management of breakthrough cancer pain in patients experiencing neuropathic pain. The subgroup analysis was supported by a grant from Meda Pharmaceuticals.