Dose titration of fentanyl pectin nasal spray in a broad range of patients for the treatment of breakthrough pain in cancer.

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. e19659-e19659
Author(s):  
A. Nguyen ◽  
A. W. Burton ◽  
J. Conroy ◽  
N. Y. Gabrail
Keyword(s):  
Nasal Spray ◽  
Breakthrough Pain ◽  
Dose Titration

Relationship between time to onset of relief and total pain relief of breakthrough pain in patients with cancer using fentanyl pectin nasal spray.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19544-e19544
Author(s):  
John D. Conroy ◽  
Luis M. Torres ◽  
Julia Revnic ◽  
Ravi Tayi ◽  
Michael Sidney Perelman ◽  
...  
Keyword(s):  
Pain Relief ◽  
Pain Intensity ◽  
Nasal Spray ◽  
Breakthrough Pain ◽  
Controlled Trial ◽  
Rapid Onset ◽  
Dose Titration ◽  
Total Pain ◽  
Time To Onset ◽  
The Relationship

e19544 Background: Breakthrough pain in cancer (BTPc) is typified by a rapid onset of severe pain with a limited duration. Treatment for BTPc requires rapid onset of pain relief. The main purpose of this analysis was to assess the relationship between time to onset of pain relief and overall pain relief in patients treating BTPc with fentanyl pectin nasal spray (FPNS, Lazanda, PecFent). Methods: Data were pooled from FPNS-treated episodes of 2 randomized, double-blind, crossover studies assessing efficacy of FPNS in adults who experienced BTPc despite background pain that was adequately controlled with at least 60 mg/day morphine (or equivalent). Patients initially entered a dose-titration phase to establish dose of FPNS (100 to 800 mcg) to be used during the treatment phase of each study. Pain intensity (PI) was assessed at baseline and scheduled time points on an 11-point scale (0=no pain, 10=worst possible pain). This analysis assessed the relationship of time to onset of pain relief (≥1 point reduction in PI from baseline) to total pain relief (Summed Pain Intensity Difference [SPID] at 30 and 60 min postdose [SPID30 and SPID60]) by ANOVA. Responses are also provided for the placebo-treated episodes during the placebo-controlled trial. Results: There were 831 episodes of BTPc that were treated with FPNS. Mean SPID was highest when pain relief was earliest (p<0.001). When PI difference (PID) ≥1 was attained by 5, 10, and 15 min postdose, mean (SD) SPID30 scores were 13.1 (6.7), 7.6 (4.0), and 3.5 (1.8). In the placebo-controlled trial, a similar overall response (p<0.001) was observed during the 200 placebo-treated episodes: among those attaining PID ≥1 by 5, 10, and 15 min postdose, SPID30 was 12.2 (7.0), 5.3 (3.3), and 2.5 (1.0), respectively. Similarly, significant differences were observed for SPID60 with both treatments. Conclusions: Earlier time to onset of pain intensity reduction in BTPc treatment resulted in higher SPID at 30 and 60 minutes postdose of FPNS and placebo. Results suggest that early onset of relief may be associated with a greater overall degree of relief for episodes of BTPc, which emphasizes the need for rapid-acting agents in the management of breakthrough pain.

Long-term tolerability of fentanyl effervescent buccal tablets: Interim analysis in patients with cancer-related breakthrough pain

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8567-8567
Author(s):  
N. Slatkin ◽  
V. Charu ◽  
G. Niebler ◽  
R. Rauck
Keyword(s):  
Interim Analysis ◽  
Breakthrough Pain ◽  
Safety Data ◽  
Dose Titration ◽  
Open Label ◽  
Patients With Cancer ◽  
Titration Phase ◽  
Term Tolerability ◽  
Buccal Tablets

8567 Background: Fentanyl effervescent buccal tablets (FEBT) are designed to enhance the rate and efficiency of fentanyl absorption through the buccal mucosa. Results reported here represent a pre-specified interim analysis of an open-label safety and efficacy study of FEBT in opioid-tolerant patients with cancer-related breakthrough pain (BTP). Methods: Patients with cancer-related BTP receiving around-the-clock and supplemental opioids were eligible to enroll. Patients who had participated in a previous dose-titration study of FEBT enrolled directly into the 1-year phase; new patients entered a titration phase to determine an effective FEBT dose before entering the 1-year phase. An effective FEBT dose was defined as the dose needed to provide adequate analgesia for BTP. By October 3, 2005, 170 patients (aged 24 to 95 years) received FEBT (100–800 μg) and had documented safety data. Results: Of the 112 new patients, 70.5% identified an effective FEBT dose and were eligible for enrollment. In the long-term phase, patients received FEBT for a mean of 109.8 days; 8% at 100 μg, 15% at 200 μg, 23% at 400 μg, 25% at 600 μg, and 29% at 800 μg. The FEBT dose remained reasonably stable during the long-term phase, but 43 patients had a dose increase and 6 had a dose decrease at the discretion of the investigator. Only 2 patients required a change in the FEBT dose because of tolerability. The most common adverse events (AEs) are given in the table. The incidence of AEs did not correlate with the effective FEBT dose. The 42 patient deaths that occurred were all attributed to cancer-related pathology or the progression of cancer. Conclusions: Overall, FEBT was well tolerated in opioid-tolerant patients with cancer-related BTP. [Table: see text] [Table: see text]

Relationship between Onset of Pain Relief and Patient Satisfaction with Fentanyl Pectin Nasal Spray for Breakthrough Pain in Cancer

2014 ◽  
Vol 17 (10) ◽  
pp. 1150-1157 ◽  
Author(s):  
Luis M. Torres ◽  
Julia Revnic ◽  
Alastair D. Knight ◽  
Michael Perelman
Keyword(s):  
Patient Satisfaction ◽  
Pain Relief ◽  
Nasal Spray ◽  
Breakthrough Pain

scholarly journals Új lehetőség a daganatos fájdalom csillapításában Magyarországon: rövid hatású major analgetikumok

2015 ◽  
Vol 156 (25) ◽  
pp. 1003-1006 ◽  
Author(s):  
Tamás Kullmann ◽  
István Sipőcz ◽  
Ágnes Csikós ◽  
Tamás Pintér
Keyword(s):  
Clinical Management ◽  
Breakthrough Pain ◽  
Oral Morphine ◽  
Dose Titration ◽  
Short Acting ◽  
Analgesic Therapy

Short acting oral morphine has recently been registered again in Hungary. Short acting oral morphine has two essential indications: dose titration at initiation of major analgesic therapy and treatment of breakthrough pain appearing beside round the clock major analgesic therapy. The clinical management of short acting oral morphine is summarised in this article. Orv. Hetil., 2015, 156(25), 1003–1006.

Long-term use of fentanyl pectin nasal spray in patients with breakthrough pain in cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9563-9563
Author(s):  
Donald Taylor ◽  
Lukas Radbruch ◽  
Julia Revnic ◽  
Luis M. Torres ◽  
John E Ellershaw ◽  
...  
Keyword(s):  
Nasal Spray ◽  
Breakthrough Pain ◽  
Controlled Trial ◽  
Oral Morphine ◽  
Opioid Therapy ◽  
Term Treatment ◽  
Open Label ◽  
Patients With Cancer ◽  
Long Term Treatment

9563 Background: Given that patients with cancer are living longer, there is a need to ensure that treatments used for palliative care are well tolerated and effective during long-term use. The objective of this study was to investigate the use of fentanyl pectin nasal spray (FPNS) for the treatment of breakthrough pain in cancer (BTPc) in patients taking regular opioid therapy. Methods: A total of 401 adult patients, taking at least 60 mg/day oral morphine or equivalent, with an average of 1 to 4 episodes of BTPc per day, who were either newly enrolled or had completed a randomized controlled trial with FPNS, entered into an open-label assessment study (NCT00458510). Of these, 171 patients, continued into an extension period. Up to 4 episodes of BTPc per day were treated with FPNS at titrated doses between 100 µg and 800 µg. Patients returned to the clinic at 4-week intervals for assessment and reporting of any adverse events (AEs). Results: There were 163 patients with documented FPNS use. The mean duration of use was 325 days; 46 patients used FPNS for more than 1 year, while the maximum duration was 3 years and 8 months. In total, 2% of patients withdrew from the study due to lack of efficacy. Seventy-four percent of patients did not change their FPNS dose. The most common AEs, aside from disease progression, were: insomnia, 9.9%; nausea, 9.4%; vomiting, 9.4%; and peripheral edema, 9.4%. The overall incidence of treatment-related AEs was 11.1%, the most common being constipation (4.1%), with no apparent dose relationship. Ten patients (5.8%) experienced treatment-related nasal AEs, which, with the exception of 1 severe event, were all mild or moderate. Conclusions: FPNS appeared to provide a sustained benefit and was well tolerated during the long-term treatment of BTPc. Clinical trial information: NCT00458510.

3011 POSTER 18-Month Safety Analysis of Fentanyl Pectin Nasal Spray (FPNS) in Patients With Breakthrough Pain in Cancer (BTPC)

2011 ◽  
Vol 47 ◽  
pp. S225 ◽  
Author(s):  
L. Torres ◽  
L. Lynch ◽  
J. Revnic ◽  
M. Ramos ◽  
C. Reale ◽  
...  
Keyword(s):  
Nasal Spray ◽  
Breakthrough Pain ◽  
Safety Analysis

Assessment and Management of Pain

2021 ◽  
pp. 214-258
Author(s):  
Russell K. Portenoy ◽  
Ebtesam Ahmed ◽  
Calvin Krom
Keyword(s):  
Chronic Illness ◽  
Severe Pain ◽  
Breakthrough Pain ◽  
Interdisciplinary Team ◽  
Dose Titration ◽  
Opioid Rotation ◽  
Team Members ◽  
Concurrent Use ◽  
Inflammatory Drugs ◽  
Disease Modifying

The management of pain associated with serious chronic illness is a core objective of palliative care. Successful therapy depends on individualization of the therapy. Management begins with a comprehensive assessment that characterizes the pain and describes it in terms of the biopsychosocial context, which includes the etiology, pathophysiology, and condition or syndrome. Nonpharmacological approaches should be considered, many of which are implemented by other interdisciplinary team members. In some cases, disease-modifying therapies may be used for analgesic purposes. The nonopioids, particularly the nonsteroidal anti-inflammatory drugs, are often adequate for initial pain management. Patients with moderate or severe pain usually are also offered an opioid, and widely accepted guidelines are available to inform safe and effective prescribing. Dose titration is usually necessary, and breakthrough pain may warrant concurrent use of fixed-schedule and “as-needed” therapy. Side effects must be anticipated and managed, and a “universal precautions” approach is prudent to mitigate the risk of abuse and addiction. If a favorable balance between analgesia and adverse effects is not realized, the patient may be poorly responsive and requires reevaluation. Opioid rotation is commonly used in this situation, as is cotreatment with one or more adjuvant analgesics, such as a glucocorticoid, antidepressant, or gabapentinoid. With guideline-based pharmacotherapy and other readily available integrative medical approaches, most patients with pain associated with serious chronic illness can obtain satisfactory relief throughout the course of their illness.

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