This randomized, double-blind, crossover study assessed the efficacy and tolerability of a new rapid onset nasal fentanyl formulation (Fentanyl Pectin Nasal Spray; FPNS) for breakthrough cancer pain (BTCP). Eighty-three of 114 patients experiencing one to four BTCP episodes/day while taking ≥60 mg/day of oral morphine or equivalent successfully identified an effective dose of FPNS during a titration phase and entered a double-blind phase in which 10 BTCP episodes were treated with this effective dose (7) or placebo (3). Compared with placebo, FPNS significantly improved mean summed pain intensity difference (SPID) from 10 min (P<0.05) until 60 min (P<0.0001), including the primary endpoint at 30 min (P<0.0001). FPNS significantly improved pain intensity (PI) scores as early as 5 min (P<0.05); pain intensity difference (PID) from 10 min (P<0.01); and pain relief (PR) scores from 10 min (P<0.001). More patients showed a clinically meaningful (≥ 2-point reduction in PI) pain reduction from 10 min onward (P ≤ 0.01) and 90.6% of the FPNS-treated versus 80.0% of placebo-treated BTCP episodes did not require rescue medication (P<0.001). Approximately 70% of patients were satisfied or very satisfied with the convenience and ease of use of FPNS. Only 5.3% of patients withdrew from treatment due to adverse events, no significant nasal effects were reported, and 87% of patients elected to continue open-label treatment post-study. In this short-term study, FPNS was safe, well tolerated, and rapidly efficacious for BTCP.
The subsurface transport of ionic and nonionic pollutants may be strongly impacted by the movement of naturally occurring dissolved organic carbon (DOC) in aquifers. Thus, the adsorption, desorption, and transport of DOC in laboratory columns containing well‐packed aquifer material was investigated. Data showed that the breakthrough of DOC from aquifer columns was the result of complex adsorption reactions between DOC and the aquifer material. Breakthrough curves (BTCs) of the DOC were characterized by an initial rapid concentration increase followed by extended tailing to long times. The extensive tailing of the BTCs was attributed primarily to the slow adsorption kinetics of DOC to the aquifer material and the nonlinear nature of the adsorption isotherm. Independent experiments suggested that the size exclusion of DOC from aquifer pores was negligible. The time required to saturate the aquifer material with organic C was dependent on the influent DOC concentration, with lower organic influent levels requiring longer pulse durations to fully saturate the aquifer sediment with organic C. Hydrophobic constituents of the DOC were preferentially adsorbed while hydrophilic components were rapidly transported through the aquifer columns. Spectral analysis (light absorbance at 260 nm) of the column effluents confirmed that the composition of the mobile organic C changed during the breakthrough of DOC. Data from this investigation demonstrate that DOC can be mobile in soil systems, and emphasizes the need to evaluate the cotransport of pollutants by DOC.
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