***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background : Fentanyl buccal soluble film ( FBSF ) has been developed as a treatment of breakthrough pain in opioid-tolerant patients with cancer . The objective of this study was to evaluate the efficacy of FBSF at doses of 200–1200 μg in the management of breakthrough pain in patients with cancer receiving ongoing opioid therapy . Patients and methods : This was a multicenter , r and omized , double-blind , placebo-controlled , multiple-crossover study that included opioid-tolerant adult patients with chronic cancer pain who experienced one to four daily episodes of breakthrough pain . The primary efficacy assessment was the sum of pain intensity differences at 30 min ( SPID30 ) postdose . Results : The intent-to-treat population consisted of 80 patients with ≥1 post-baseline efficacy assessment . The least-squares mean ( LSM ± SEM ) of the SPID30 was significantly greater for FBSF-treated episodes of breakthrough pain than for placebo-treated episodes ( 47.9 ± 3.9 versus 38.1 ± 4.3 ; P = 0.004 ) . There was statistical separation from placebo starting at 15 min up through 60 min ( last time point assessed ) . There were no unexpected adverse events ( AEs ) or clinical ly significant safety findings . Conclusions : FBSF is an effective option for control of breakthrough pain in patients receiving ongoing opioid therapy . In this study , FBSF was well tolerated in the oral cavity , with no reports of treatment-related oral AEs Purpose Instanyl ® ( intranasal fentanyl spray ) is a novel treatment for breakthrough pain ( BTP ) in cancer patients . It has shown a rapid onset of pain relief in clinical trials . This study examines the use of Instanyl ® in real-life setting s. Methods A 3-month observational , prospect i ve , cohort study of cancer patients with BTP receiving Instanyl ® ( 50 , 100 , or 200 μg ) under routine clinical practice . Data were collected at three time points corresponding with routine clinic visits – baseline , Week 4 , and Week 13 . Primary outcomes : success of titration and maintenance dose after titration . Secondary outcomes : change in maintenance dose of  Instanyl ® and level of background pain medication ; Brief Pain Inventory — Short Form ( BPI-SF ) and Patient Treatment Satisfaction Scale ( PTSS ) scores ; adverse drug reactions ( ADRs ) . Results Titration with Instanyl ® was successful in 84.5 % of 309 patients ; most patients were titrated at the lowest dose ( 50 μg ) . The majority showed no change in maintenance dose , with little change in the level of background pain medication . BPI-SF and PTSS scores significantly improved from baseline to Week 4 . The main reason for terminating Instanyl ® was death , as expected due to the underlying disease ; incidence of ADRs was low and no fatal ADRs were reported . Conclusions In a real-life group of cancer patients with disease progression  , Instanyl ® was titrated successfully at doses < 200 μg in the majority of patients , requiring only one dose , with no further change in maintenance dose . Pain severity , impact of pain on daily life , and treatment satisfaction significantly improved with Instanyl ® treatment . No unexpected ADRs occurred & NA ; Oral transmucosal fentanyl citrate ( OTFC ® ; Actiq ® ) is a drug delivery formulation used for management of breakthrough cancer pain . Previous studies with open‐label comparisons indicated OTFC was more effective than patients ’ usual opioid for breakthrough pain . The objective of this study was to compare OTFC and morphine sulfate immediate release ( MSIR ® ) for management of breakthrough pain in patients receiving a fixed scheduled opioid regimen . This double‐blind , double‐dummy , r and omized , multiple crossover study was conducted at 19 US university‐ and community‐based hospitals and clinics and comprised 134 adult ambulatory cancer patients . Patients were receiving a fixed scheduled opioid regimen equivalent to 60–1000 mg/day oral morphine or 50–300 & mgr;g/h transdermal fentanyl  , were using a ‘ successful ’ MSIR dose ( 15–60 mg ) as defined by entry criteria , and were experiencing 1–4 episodes of breakthrough pain per day . In open‐label fashion , OTFC was titrated such that a single unit ( 200–1600 & mgr;g ) provided adequate pain relief with acceptable side effects . Successfully titrated patients entered the double‐blind phase of the study and received ten prenumbered sets of r and omized capsules and oral transmucosal units . Five sets were the successful OTFC dose paired with placebo capsules , and five sets were placebo OTFC paired with capsules containing the successful MSIR dose . Patients took one set of study medication for each episode of target breakthrough pain . Pain intensity ( PI ) , pain relief ( PR ) and global performance of medication ( GP ) scores were recorded . Pain intensity differences ( PID ) were calculated and 15‐min PID was the primary efficacy variable . Adverse events were recorded . Sixty‐nine percent of patients ( 93/134 ) found a successful dose of OTFC . OTFC yielded outcomes ( PI , PID , and PR ) at all time points that were significantly better than MSIR . GP also favored OTFC and more patients opted to continue with OTFC than MSIR following the study . Somnolence , nausea , constipation , and dizziness were the most common drug‐associated side effects . In conclusion , OTFC was more effective than MSIR in treating breakthrough cancer pain Abstract Background and objectives : Breakthrough cancer pain ( BTcP ) represents an important clinical challenge in the care of patients with cancer . This trial evaluated the efficacy and long-term tolerability of a sublingual formulation of the fast-acting opioid fentanyl , for the treatment of BTcP in opioid-tolerant patients with cancer . Research design and methods : This was a r and omized , placebo-controlled , multi-center , phase III trial , conducted in opioid-tolerant male and female patients ( aged ≥17 years ) with BTcP. The study was conducted at 36 centers across the USA . The study comprised a 2-week open-label titration phase , followed by a double-blind efficacy phase , during which patients received sublingual fentanyl citrate orally disintegrating tablet ( sublingual fentanyl ODT ) or placebo , in a r and om order . The primary efficacy endpoint was the sum of pain intensity difference ( SPID ) over 30 min post-administration . Secondary efficacy endpoints included pain intensity difference ( PID ) and pain relief ( PR ) throughout the 60-min post-dose assessment period . Following efficacy evaluation , patients entered a long-term safety phase of up to 12 months . Adverse events were recorded throughout the study . [ Clinical trial registration : NCT00262678 ] Results : A total of 131 patients entered the titration phase , of whom 61 were included in the primary efficacy analysis . Sublingual fentanyl ODT provided significant improvements in SPID relative to placebo at 30 min ( 49.5 vs. 36.6 , p = 0.0004 ) and 60 min post-administration ( 143.0 vs. 104.5 , p = 0.0002 ) . Furthermore , sublingual fentanyl ODT provided significant improvements in PID and PR compared to placebo , from 10 min post-dose ( p = 0.0055 and p = 0.049 for PID and PR , respectively ) . Patient recruitment was stopped early , due to positive interim analysis results ( significant at prespecified level , p ≤ 0.0414 ) . Overall , sublingual fentanyl ODT was well-tolerated both systemically and sublingually , with 41 patients experiencing ≥1 study drug-related adverse event ( AE ) . The most common AEs included nausea ( 12.2 % ) , vomiting ( 5.3 % ) and somnolence ( 4.6 % ) . One serious AE ( mild affect lability ) was considered possibly related to study medication . The observed pattern of AEs was consistent with that previously observed with fentanyl . Conclusions : Sublingual fentanyl ODT was efficacious and well-tolerated for the treatment of BTcP in opioid-tolerant patients with cancer . Sublingual fentanyl ODT provided significant improvements in pain intensity compared to placebo , from 10 min post-administration and throughout the 60-min post-dose assessment period . Sublingual fentanyl ODT was well tolerated over 12 months of treatment Abstract Objective : The efficacy of intranasal fentanyl spray ( INFS ) was compared with that of oral transmucosal fentanyl citrate ( OTFC ) for the relief of cancer-related breakthrough pain ( BTP ) in an open-label , crossover trial . Methods : Adult cancer patients receiving stable background opioid treatment and experiencing BTP episodes were recruited from 44 study centres in seven European countries ( Austria , France , Germany , Italy , Pol and , Spain and the United Kingdom ) ; of the 196 patients enrolled , 139 were r and omised to receive INFS followed by OTFC  , or vice versa . Patients were titrated to an effective dose of one agent ( 50 , 100 or 200 µg INFS ; 200 , 400 , 600 , 800 , 1200 or 1600 µg OTFC ) to treat six BTP episodes , then titration and treatment were repeated with the other agent . The primary outcome was patient-recorded time to onset of ‘ meaningful ’ pain relief . Secondary outcomes included pain intensity difference ( PID ) at 10 and 30 minutes ( PID10 , PID30 ) , sum of PID at 15 and 60 minutes ( SPID0–15 , SPID0–60 ) , ease of administration , treatment preference and relationship between background opioid dose and effective INFS dose . Additional outcome measures included proportions of episodes with ≥33 % and ≥50 % pain intensity ( PI ) reduction , and PID at additional time points . Clinical trial registration number : NCT00496392 . Results : Among the intention-to-treat population ( n = 139 ) , median time to onset of ‘ meaningful ’ pain relief was 11 minutes with INFS versus 16 minutes with OTFC ; 65.7 % of patients attained faster time to ‘ meaningful ’ pain-relief onset with INFS ( p < 0.001 ) . PID was statistically significantly greater for INFS than OTFC from 5 minutes post-dosing . Significantly more INFS-treated breakthrough pain episodes achieved clinical ly important pain relief ( ≥33 % and ≥50 % PI reduction ) up to 30 minutes post-dosing . The proportions of episodes treated with INFS and OTFC achieving a PI reduction of ≥33 % at 5 minutes were 25.3 % versus 6.8 % ( p < 0.001 ) , and at 10 minutes were 51.0 % versus 23.6 % ( p < 0.001 ) , respectively ; the proportions of episodes treated with INFS and OTFC achieving a ≥50 % PI reduction at 5 minutes were 12.8 % versus 2.1 % ( p < 0.001 ) , and at 10 minutes were 36.9 % versus 9.7 % ( p < 0.001 ) , respectively . Higher SPID0–15 and SPID0–60 scores were achieved with INFS ( p < 0.001 ) . More patients preferred INFS than OTFC ( p < 0.001 ) and more patients found it very easy/easy to use . Both treatments were well tolerated . In the safety population ( n = 139 ) , 56.8 % ( n = 79 ) of patients experienced ≥1 AE during the trial . The only AE that occurred in ≥5 % of patients in either treatment group was nausea . Among those patients who experienced serious AEs ( 13.7 % , n = 19 ) , none were considered to be related to either study medication . There was a weak correlation between effective INFS doses and background opioid doses . Conclusion : In this open-label , r and omised , crossover trial , significantly more patients attained faster ‘ meaningful ’ pain relief  with INFS than OTFC , and more patients preferred INFS to OTFC Objectives To determine the efficacy and safety of different opioids used in doses proportional to the basal opioid regimen for the management of breakthrough pain ( BP ) . Methods In 66 patients consecutive patients admitted to a pain relief and palliative care unit , the efficacy and safety of different opioids used in doses proportional to the basal opioid regimen for the management of breakthrough pain ( BP ) were assessed . The choice of the opioid to be administered as rescue medication was based on the characteristics of patients , clinical stability , compliance , preference , and so on . For each episode , nurses were instructed to routinely collect changes in pain intensity and emerging problems when pain became severe ( T0 ) , and to re-assess the patient 15 minutes after the opioid given as a rescue medication ( T15 ) . Results Six hundred twenty four episodes of BP were recorded during admission . Intravenous morphine ( IV-MO ) and oral transmucosal fentanyl ( OTFC ) were most frequently administered . Of 503 events available , 427 episodes were defined as successfully treated , while 76 episodes required a further administration of opioids . Pain intensity significantly decreased at T15 in all the groups ( P<0.001 ) 
    Output:
    
Transmucosal immediate‐release fentanyl ( TIRF ) was found to have the most evidence for BtCP .