Tolerability and effects of two formulations of oral transmucosal fentanyl citrate (OTFC; ACTIQ) in patients with radiation-induced oral mucositis

Background. Oral transmucosal fentanyl citrate (OTFC; ACTIQ) incorporates fentanyl into a lozenge allowing drug delivery through the oral mucosa resulting in rapid pain relief. OTFC is effective for breakthrough pain and could be particularly useful in patients with mucositis. Methods. This randomized, double-blind, crossover study assessed two formulations of OTFC for tolerability in 14 patients with radiation-induced mucositis. On four separate days, patients with grade 3 or 4 mucositis received an OTFC unit 45 min before radiation treatment. Two units had a sweetened matrix formulation and two had a compressed powder formulation. One unit of each formulation contained 200 mug fentanyl and one was placebo. Tolerability, mucositis pain, and formulation preference were evaluated. Changes in oral mucosa were recorded. Results. Both formulations of OTFC were well tolerated. There were no significant differences between formulations in tolerability, patient preference, or VAS pain scores. No changes in oral mucosa were noted. Common treatment-related adverse events included a burning sensation in the mouth, nausea, and vomiting. Conclusions. Both formulations of OTFC are well tolerated. The presence of fentanyl in either the sweetened matrix or the compressed powder did not alter tolerability or safety. The dose of fentanyl tested did not yield analgesia greater than placebo; future studies of OTFC efficacy in mucositis should evaluate higher doses than 200 mug.