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      Considerations in selecting rapid-onset opioids for the management of breakthrough pain

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      Journal of Pain Research

      Dove Medical Press

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          Abstract

          Dear editor We read with great interest the recent publication by Smith.1 This article provides a valuable perspective on the selection of an agent to manage breakthrough pain. Smith recognizes the importance of a fast onset-of-action and the identification by Farrar et al2 of a 33% (often ≥2 point) change in the pain intensity difference as a measure of a ‘clinically important improvement’. For these reasons, Smith focuses on the various transmucosal fentanyl formulations that offer a rapid onset and he provides a nice summary of the key features of each of the available products. Smith1 also provides some ‘advantages and disadvantages’ of different routes of administration which can be used to select an appropriate formulation for an individual patient. We agree with much of the commentary presented but feel that the grouping of dissimilar formulations based on route of administration is potentially too simple. For example, Smith1 includes two different products in the intranasal route discussion, despite earlier recognition of key formulation differences, and in doing so allocates weaknesses of one formulation to the other. We would like to inform readers of three important points regarding one intranasal fentanyl formulation: First, fentanyl pectin nasal spray (Lazanda®/PecFent® Archimedes Development Ltd Nottingham, UK) includes the unique PecSys® technology that forms a bioadhesive gel on the nasal mucosa, which significantly reduces run-off/drip compared with a simple solution.3,4 This means that the fentanyl is retained in the nasal cavity and that variable absorption associated with nasal drip or swallowing is not an issue for fentanyl pectin nasal spray. Other formulations (nasal and oral) explicitly acknowledge in their prescribing information, the potential for variable absorption.5,6 Secondly, the absorption of fentanyl from fentanyl pectin nasal spray has been specifically studied in patients with rhinitis;7 in that setting the absorption of fentanyl was not affected by nasal inflammation (area under the curve from time 0 to time of last quantifiable plasma concentration, area under the curve from time 0 to 1 hour after administration, maximum plasma concentration, and time to maximum plasma concentration) – which by implication suggests that patients with colds or illnesses that result in changes to the nasal mucosa are suitable candidates for fentanyl pectin nasal spray. Finally, data from fentanyl pectin nasal spray Phase III trials8–10 show that patients did not have difficulty using the spray device; in fact the vast majority reported a high degree of satisfaction. We agree with Smith’s conclusions1 that treatment selections should be based on patient needs, but we felt it important to offer an added perspective on the criteria being used to make such a selection.

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          Most cited references 9

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          PecSys: in situ gelling system for optimised nasal drug delivery.

          PecSys (PS) is a proprietary pectin-based drug delivery system designed to gel when applied to mucosal surfaces and with potential areas of application for drugs used in local and systemic disease therapy. The current area of focus is intranasal drug delivery where PS is being used to optimise absorption of lipophilic drugs into the systemic circulation. Pectin is described as GRAS (generally regarded as safe) with an excellent regulatory position through its long history of pharmaceutical and food usage. Tests to measure the functional gelling properties of pectin raw material and PS have been devised and validated. The PS-based products at the most advanced stages of development are intranasal formulations containing opioid analgesics intended to provide rapid pain relief with simple and convenient dosing and minimal side effects. The profile of such drugs may not be optimal through current routes of delivery and the ability of PS to modulate their pharmacokinetic profiles, such as attenuation of the peak plasma concentration (Cmax), has been demonstrated in clinical testing. The lead product using PS is a fentanyl nasal spray formulation (NasalFent), which has successfully met the primary objective in a pivotal Phase III clinical study and is scheduled for regulatory filings in the first half of 2009.
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            Consistency of efficacy, patient acceptability, and nasal tolerability of fentanyl pectin nasal spray compared with immediate-release morphine sulfate in breakthrough cancer pain.

            We recently reported that fentanyl pectin nasal spray (FPNS) provides superior pain relief from breakthrough cancer pain (BTCP) compared with immediate-release morphine sulfate (IRMS), with significant effects by five minutes and clinically meaningful pain relief from 10 minutes postdose. To report the consistency of efficacy, tolerability, and patient acceptability of FPNS vs. IRMS. Patients (n=110) experiencing one to four BTCP episodes/day while taking ≥60 mg/day oral morphine (or equivalent) for background pain entered a double-blind, double-dummy (DB/DD), multiple-crossover study. Those who completed an open-label titration phase (n=84) continued to a DB/DD phase; 10 episodes were randomly treated with FPNS and overencapsulated placebo or IRMS and nasal spray placebo (five episodes each). Pain intensity (PI) and pain relief scores were assessed. Patient acceptability scores were assessed at 30 and 60 minutes. Safety and tolerability were assessed by adverse events (AEs) and nasal assessments. Per-episode analysis revealed that FPNS consistently provided relief from pain more rapidly than IRMS; by 10 minutes, there were significant differences in PI difference scores and in the percentages of episodes showing clinically meaningful pain relief (P<0.05). Overall acceptability scores were significantly greater for FPNS than for IRMS at 30 (P<0.01) and 60 (P<0.05) minutes. Patients were "satisfied/very satisfied" with the convenience (79.8%) and ease of use (77.2%) of FPNS. Only 4.7% of patients withdrew from titration because of AEs; no significant nasal effects were reported. This study demonstrates that FPNS is efficacious, well accepted, and well tolerated by patients with BTCP. Copyright © 2011 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.
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              Fentanyl pectin nasal spray in breakthrough cancer pain.

              Abstract Fentanyl pectin nasal spray (FPNS) is being developed to improve analgesic onset, treatment efficacy, and satisfaction/acceptability in treating breakthrough cancer pain (BTCP). Patients (n = 114) were entered into a randomized, placebo-controlled, double-blind, multicenter study. Patients who successfully titrated (n = 83) entered a double-blind phase; 10 episodes of BTCP were treated with the effective dose (7) or placebo (3). Pain intensity (11-point scale) and pain relief (5-point scale) were assessed between 5 and 60 minutes. Use of rescue medications was recorded, and acceptability assessments were conducted 30 and 60 minutes post dose. Only 6% of patients failed to titrate to an effective dose of FPNS due to lack of efficacy and 5% due to adverse events. A total of 91% of randomized patients completed the study. Episode analysis (FPNS, n = 459; placebo, n = 200) revealed that compared with placebo, 33% of FPNS episodes showed an onset of improvement in pain intensity at 5 minutes (P or = 2 point decrease in pain intensity; P < 0.0001). Satisfaction with the convenience and ease of use of FPNS was reported by 70% and 68% of patients, respectively; 87% of patients elected to continue treatment post study. FPNS provided rapid analgesia in BTCP and was well accepted by patients.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                Journal of Pain Research
                Dove Medical Press
                1178-7090
                2013
                05 June 2013
                : 6
                : 435-436
                Affiliations
                Archimedes Pharma, Bedminister, NJ, USA
                Author notes
                Correspondence: Suzan Leake, Archimedes Pharma, One Crossroads Drive, Bedminister, NJ 07921, USA Email suzanleake@ 123456archimedespharma.com
                Article
                jpr-6-435
                10.2147/JPR.S45774
                3682851
                23785243
                © 2013 Perelman and Leake, publisher and licensee Dove Medical Press Ltd

                This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

                Categories
                Letter

                Anesthesiology & Pain management

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