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satisfaction with fentanyl buccal tablet compared to traditional short-acting opioids for the management of breakthrough pain in opioid-tolerant patients with chronic pain
P62
The Journal of Pain
(344) Withdrawn
Abstracts (346) Time dependency of adverse events with ButransÔ (buprenorphine) transdermal system W Wen, S Lynch, C Munera, and S Ripa; Purdue Pharma LP, Stamford, CT Temporal relationship of adverse event (AE) occurrence with drug exposure is an important component in assessing the overall tolerability profile of a drug. The Butrans (buprenorphine) Transdermal System uses a matrix system that delivers buprenorphine continuously over a 7-day period at 3 dose strengths: 5, 10, and 20 mcg buprenorphine/hour. The analyses examine the time dependence of AE occurrence in relation to Butrans exposure in chronic pain subjects. The time dependency of AE onset during Butrans exposure across study periods (run-in, double-blind, and open-label extension) was analyzed using pooled data from 15 studies. The Kaplan-Meier methodology was used to examine the relationship between exposure time and the first occurrence of selected AEs. To determine the effect of prolonged Butrans exposure, the incidence and prevalence of AEs in 2-month intervals (0-2, 3-4, and 5-6 months) were examined in subjects with $6 months of continuous Butrans exposure. Among the 5415 Butrans-treated subjects, the rate for new onset of the following AEs was highest within the first 30 days of treatment: nausea, vomiting, dizziness, somnolence/lethargy/sedation, headache, fatigue, constipation, pruritus/ pruritus generalized, dry mouth, application site pruritus and application site rash. By contrast, the rate of new onset application site erythema and application site irritation remained similar over the course of Butrans exposure. In subjects with $6 months of continuous Butrans exposure, the prevalence of AEs decreased only slightly over time, whereas the incidence of new onset AEs decreased more substantially over the three 2-month intervals. In contrast, application site erythema showed an increase in prevalence while the incidence of new onset events remained constant over the 6-month interval. In general, the incidence and prevalence of most AEs decreased with prolonged Butrans treatment. A few AEs, such as application site erythema and application site rash continued to occur at relatively constant rate throughout BTDS treatment.
(345) Functioning/satisfaction with fentanyl buccal tablet compared to traditional short-acting opioids for the management of breakthrough pain in opioid-tolerant patients with chronic pain
(347) Application site adverse events of ButransÔ (buprenorphine) transdermal system
L Webster, A Narayana, and L Janka; Cephalon, Inc., Frazer, PA
Butrans (buprenorphine) Transdermal System, a matrix system, delivers buprenorphine continuously for a 7-day period at 3 dose strengths: 5, 10, and 20 mcg/ hour. The active ingredient in the Butrans system is buprenorphine. The excipients include levulinic acid, oleyl oleate, povidone, and polyacrylate crosslinked with aluminum. These analyses characterize the profile of application site adverse events (AEs) for Butrans in chronic pain studies. The incidence of application site AEs during treatment with Butrans (across the run-in, double-blind, and open-label extension periods) was examined using pooled data from 15 studies. The incidences of these AEs between Butrans and placebo were compared during the double-blind period in controlled studies; all patients in control arms received placebo patches (identical to Butrans except for absence of buprenorphine). Of the 5415 subjects, 24.7% experienced $1 application site AE. The most common application site AEs were pruritus (14.3%) and erythema (8.9%). The application site AEs were mild or moderate in intensity and none were serious. Treatment discontinuation due to application site AEs occurred infrequently, including pruritus (1.9%) and erythema (1.6%). Of the 2130 Butrans-treated and 995 placebo-treated patients in controlled studies, application site AE rates were higher in Butrans-treated subjects than placebo-treated subjects (22.8% vs 17.1%). In clinical trials, Butrans presents a well tolerated application site AE profile in most patients.
There are limited data directly comparing different treatments for breakthrough pain (BTP). After obtaining IRB approval and informed written consent, opioid-tolerant adults with BTP who completed a randomized, double-blind, crossover study were re-randomized to fentanyl buccal tablet (FBT) or any traditional short-acting opioid (SAO) for 12 weeks of open-label treatment. Patients/clinicians completed the following functionality/satisfaction assessments: Patient Assessment of Function (PAF), Clinician Assessment of Patient Function (CAPF), Patient Global Impression of Change (PGIC), and Clinical Global Impression of Change (CGIC). All assessments were rated on a 7-point scale, from very much worsened to very much improved. 130 patients received treatment (65, FBT; 65, SAO). For the PAF, more patients receiving FBT than SAO reported improvement in 11 of 12 areas of functioning (P<0.05 for 7 areas of functioning), including improvement in enjoyment of life (72% vs 43%; P=0.001 for the distribution of responses). For the CAPF, clinicians reported that more patients improved in all 12 areas of functioning (P<0.05 for 6 areas of functioning) with FBT than SAO, including improvement in enjoyment of life (68% vs 38%; P<0.001). Responses to the PGIC and CGIC also favored FBT vs SAO (PGIC: mean [SD] 1.5 [1.02] vs 0.9 [1.09]; CGIC: 1.4 [1.01] vs 0.7 [1.05]; both P<0.001). Adverse events were generally similar between treatments and typical of opioids. In conclusion, following 12 weeks of open-label treatment, patients and clinicians reported consistently better efficacy, including functional improvement, with FBT than with traditional SAOs in opioid-tolerant patients with BTP. Supported by Cephalon, Inc.
W Wen, S Lynch, C Munera, S Ripa, and H Maibach; Purdue Pharma LP, Stamford, CT
The Journal of Pain
(344) Withdrawn
Abstracts (346) Time dependency of adverse events with ButransÔ (buprenorphine) transdermal system W Wen, S Lynch, C Munera, and S Ripa; Purdue Pharma LP, Stamford, CT Temporal relationship of adverse event (AE) occurrence with drug exposure is an important component in assessing the overall tolerability profile of a drug. The Butrans (buprenorphine) Transdermal System uses a matrix system that delivers buprenorphine continuously over a 7-day period at 3 dose strengths: 5, 10, and 20 mcg buprenorphine/hour. The analyses examine the time dependence of AE occurrence in relation to Butrans exposure in chronic pain subjects. The time dependency of AE onset during Butrans exposure across study periods (run-in, double-blind, and open-label extension) was analyzed using pooled data from 15 studies. The Kaplan-Meier methodology was used to examine the relationship between exposure time and the first occurrence of selected AEs. To determine the effect of prolonged Butrans exposure, the incidence and prevalence of AEs in 2-month intervals (0-2, 3-4, and 5-6 months) were examined in subjects with $6 months of continuous Butrans exposure. Among the 5415 Butrans-treated subjects, the rate for new onset of the following AEs was highest within the first 30 days of treatment: nausea, vomiting, dizziness, somnolence/lethargy/sedation, headache, fatigue, constipation, pruritus/ pruritus generalized, dry mouth, application site pruritus and application site rash. By contrast, the rate of new onset application site erythema and application site irritation remained similar over the course of Butrans exposure. In subjects with $6 months of continuous Butrans exposure, the prevalence of AEs decreased only slightly over time, whereas the incidence of new onset AEs decreased more substantially over the three 2-month intervals. In contrast, application site erythema showed an increase in prevalence while the incidence of new onset events remained constant over the 6-month interval. In general, the incidence and prevalence of most AEs decreased with prolonged Butrans treatment. A few AEs, such as application site erythema and application site rash continued to occur at relatively constant rate throughout BTDS treatment.
(345) Functioning/satisfaction with fentanyl buccal tablet compared to traditional short-acting opioids for the management of breakthrough pain in opioid-tolerant patients with chronic pain
(347) Application site adverse events of ButransÔ (buprenorphine) transdermal system
L Webster, A Narayana, and L Janka; Cephalon, Inc., Frazer, PA
Butrans (buprenorphine) Transdermal System, a matrix system, delivers buprenorphine continuously for a 7-day period at 3 dose strengths: 5, 10, and 20 mcg/ hour. The active ingredient in the Butrans system is buprenorphine. The excipients include levulinic acid, oleyl oleate, povidone, and polyacrylate crosslinked with aluminum. These analyses characterize the profile of application site adverse events (AEs) for Butrans in chronic pain studies. The incidence of application site AEs during treatment with Butrans (across the run-in, double-blind, and open-label extension periods) was examined using pooled data from 15 studies. The incidences of these AEs between Butrans and placebo were compared during the double-blind period in controlled studies; all patients in control arms received placebo patches (identical to Butrans except for absence of buprenorphine). Of the 5415 subjects, 24.7% experienced $1 application site AE. The most common application site AEs were pruritus (14.3%) and erythema (8.9%). The application site AEs were mild or moderate in intensity and none were serious. Treatment discontinuation due to application site AEs occurred infrequently, including pruritus (1.9%) and erythema (1.6%). Of the 2130 Butrans-treated and 995 placebo-treated patients in controlled studies, application site AE rates were higher in Butrans-treated subjects than placebo-treated subjects (22.8% vs 17.1%). In clinical trials, Butrans presents a well tolerated application site AE profile in most patients.
There are limited data directly comparing different treatments for breakthrough pain (BTP). After obtaining IRB approval and informed written consent, opioid-tolerant adults with BTP who completed a randomized, double-blind, crossover study were re-randomized to fentanyl buccal tablet (FBT) or any traditional short-acting opioid (SAO) for 12 weeks of open-label treatment. Patients/clinicians completed the following functionality/satisfaction assessments: Patient Assessment of Function (PAF), Clinician Assessment of Patient Function (CAPF), Patient Global Impression of Change (PGIC), and Clinical Global Impression of Change (CGIC). All assessments were rated on a 7-point scale, from very much worsened to very much improved. 130 patients received treatment (65, FBT; 65, SAO). For the PAF, more patients receiving FBT than SAO reported improvement in 11 of 12 areas of functioning (P<0.05 for 7 areas of functioning), including improvement in enjoyment of life (72% vs 43%; P=0.001 for the distribution of responses). For the CAPF, clinicians reported that more patients improved in all 12 areas of functioning (P<0.05 for 6 areas of functioning) with FBT than SAO, including improvement in enjoyment of life (68% vs 38%; P<0.001). Responses to the PGIC and CGIC also favored FBT vs SAO (PGIC: mean [SD] 1.5 [1.02] vs 0.9 [1.09]; CGIC: 1.4 [1.01] vs 0.7 [1.05]; both P<0.001). Adverse events were generally similar between treatments and typical of opioids. In conclusion, following 12 weeks of open-label treatment, patients and clinicians reported consistently better efficacy, including functional improvement, with FBT than with traditional SAOs in opioid-tolerant patients with BTP. Supported by Cephalon, Inc.
W Wen, S Lynch, C Munera, S Ripa, and H Maibach; Purdue Pharma LP, Stamford, CT