Oral normal-release morphine has long been considered the gold-standard treatment for cancer breakthrough pain. However, its relatively long time to analgesic onset, delay in maximal analgesic effect and prolonged duration of action make it unsuitable for the management of breakthrough pain episodes. These limitations led to the development of an oral transmucosal formulation of the fast-acting opioid fentanyl (oral transmucosal fentanyl citrate [OTFC] lozenge on a plastic handle; Actiq®), which has been shown to produce more rapid and effective pain relief than oral morphine. However, the formulation itself has some limitations. Consequently, investigators have continued to develop other, newer generation, transmucosal formulations of fentanyl to further improve the management of breakthrough pain. Recently, five such compounds (Effentora®/Fentora®, Abstral®, Instanyl®, Breakyl®/OnsolisTM and PecFent®) have been concurrently approved in Europe and/or the US, and have documented efficacy in quickly relieving breakthrough pain episodes. All of the available pivotal efficacy trials of these agents are randomized, double-blind comparisons with placebo. There are no head-to-head trials comparing any of the newer transmucosal formulations with each other. Only one non-pivotal study of intranasal fentanyl spray used a transmucosal preparation as an active comparator. However, that comparator was OTFC, not one of the newer transmucosal products. Close examination of the existing trials assessing these newer transmucosal preparations reveals significant variation in many study parameters, such as patient selection criteria, severity of breakthrough pain episodes, proportions of patients with a neuropathic pain component, titration protocols, choice of the primary endpoints, protocols for repeat dosing and rescue medication, the separation of treated episodes and the extent of the placebo response, all of which may have affected efficacy results. It is therefore difficult to evaluate the relative efficacies of these treatments on the basis of the available trials. Furthermore, given the differences in design between studies, the value of any potential meta-analyses including these trials would likely be limited. Blinded head-to-head comparisons of new transmucosal fentanyl preparations would be the only way to conclusively determine comparative effectiveness, but given the impracticalities of conducting such studies, these are unlikely.

Factors that influenced the choice of dose of oral transmucosal fentanyl at the time of burns dressing change were investigated in a prospective study. After Ethics committee approval, data was analysed from 29 consecutive patients who had been recruited and consented for a study of pain associated with burns dressings. Patients had completed an 11-point verbal pain intensity score (VRS) prior to and after the dressing change. Analgesic use during for this period was documented. Doses of 600 to 1200 mcg of transmucosal fentanyl (Actiq) were given based on individual assessment. The pre-dressing VRS (median [range]) in the 15 patients who received 600 mcg was 8 [3-10] and was higher than the VRS of 6 [2-9] in the 800-1200 mcg group. The time since the burn was longer in the low dose group at 7 [1-22] days compared with 5 [0-50] days in the higher dose group. In addition 73% of the low dose group was prescribed opioids regularly prior to the dressing compared with 57% of the high dose group. The choice of a lower transmucosal fentanyl dose was based on prior use of opioids and the age of the burn rather than on the patient's pain intensity.

Between 40 and 80% of patients with advanced cancer experience breakthrough pain (BTP), a sudden, rapidly escalating flare of pain occurring against a background of otherwise well-controlled persistent pain. Patients often have up to four episodes of BTP each day, with a typical episode reaching its peak intensity in three to five minutes and lasting about 30 minutes in total. It is essential to provide fast and effective relief since BTP reduces the quality of life of patients and their families, and increases health care costs. The usual approach is to treat BTP with a short-acting, 'normal release' oral opioid, but this is absorbed too slowly to treat the typical episode of BTP. As this article explains, oral transmucosal fentanyl citrate (Actiq) is an effective strong opioid that has a rapid onset and short duration of action that closely matches the characteristics of an episode of BTP.

As a result of improved survival in cancer and the transfer of care from hospital to primary care, community nurses are taking increasing responsibility for the management of patients at all stages of the disease. Persistent or background pain is common, but between 40% and 80% of patients with advanced cancer also experience breakthrough pain (BTP), a sudden, rapidly escalating flare of pain occurring against a background of otherwise well-controlled persistent pain. While background pain can be successfully managed in most patients, BTP presents a particular challenge to community nurses, because short-acting, 'normal release' oral opioid drugs are absorbed too slowly to treat the typical episode. As this article explains, Actiq is an effective strong opioid with a rapid onset and short duration of action that closely matches the characteristics of an episode of BTP.

Pain is experienced by most cancer patients and represents an important issue in the clinical setting. Breakthrough pain is a transitory flare of pain that occurs in most cancer patients on a background of otherwise controlled persistent pain. Treatment of breakthrough pain is a challenging phenomenon. Oral transmucosal fentanyl citrate (OTFC; Actiq, Cephalon, UK), a new opioid formulation with a unique delivery system, utilizing the advantages that nanotechnology offers, reflects the characteristics of breakthrough pain (rapid onset of action and short duration), which makes it an effective treatment to cancer patients who are already receiving opioids and continue to experience such flares of pain. Oral transmucosal fentanyl citrate is specifically developed and approved for the management of breakthrough pain in cancer patients and it has the potential to be a useful tool for clinicians.

To characterize breakthrough pain (BTP), its qualitative impact on quality of life (QoL), and the effects of BTP treatment on QoL.Multicenter patient-reported survey.Five pain treatment centers.Fifty-six adults with chronic noncancer pain using oral transmucosal fentanyl citrate (OTFC, ACTIQ).Forty-three patients qualified for in-depth analysis. BTP had a mean intensity of 9.0 (range 5-10) on an 11-point numerical scale (0 = no pain to 10 = worst possible pain), had a mean duration of 83 minutes, and had an adverse effect on multiple QoL domains. The largest negative QoL impacts were on "general activity level" and "ability to work." OTFC had a positive impact on both controlling BTP and improving QoL.BTP appears to be a clinically important condition in this population and is associated with an adverse impact on QoL. Understanding those QoL domains most affected by BTP and those potentially improved with treatment should help in developing quantitative QoL assessment tools and other outcome measures for BTP management studies.