Fentanyl buccal tablet for the treatment of breakthrough pain in systemic mastocytosis – a case study

Objective: To evaluate the effect of fentanyl buccal tablet (FBT) on pain-related anxiety in opioid-tolerant patients with chronic pain and breakthrough pain (BTP).Design: This study consisted of a screening visit, open-label titration period, and 4-week open-label treatment period.Setting: Thirty-one US study centers.Patients: Opioid-tolerant adults with chronic, persistent pain experiencing 1-4 BTP episodes per day at baseline. Two hundred eighteen patients were enrolled in this study; 180 completed the titration period; and 169 completed the treatment period.Intervention: Patients were treated with FBT (100-800 g) for BTP episodes for 4 weeks while continuing their around-the-clock opioid regimens.Main outcome measures: Change from baseline in the Pain Anxiety Symptoms Scale (PASS) total score at the final visit.Results: Based on a mean baseline PASS total score of 82.6, study patients had a high level of anxiety; 92 patients (42 percent) had a history of anxiety disorders. The change from baseline in PASS total score was not statistically significant (mean change, −1.6; p = 0.322). Numerical improvements were reported in some secondary measures (eg, Beck Depression Inventory total score [mean change, −1.1; p = 0.038]) and categorical measures (eg, Pain Flare Treatment Satisfaction, Patient Assessment of Function, and Clinician Assessment of Patient Function ratings). FBT was generally well tolerated, with no serious adverse events related to study drug.Conclusions: Four weeks of treatment with FBT did not reduce anxiety to a clinically meaningful extent, although improvement was reported in several secondary measures of functioning. Further research is needed to assess the impact of treatment for BTP on anxiety symptoms in opioid-tolerant patients with BTP.

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Fentanyl Buccal Tablet for the Treatment of Breakthrough Pain: Pharmacokinetics of Buccal Mucosa Delivery and Clinical Efficacy

Perspectives in Medicinal Chemistry ◽

10.4137/pmc.s3928 ◽

2010 ◽

Vol 4 ◽

pp. PMC.S3928 ◽

Cited By ~ 8

Author(s):

Mona Darwish ◽

Ehab Hamed ◽

John Messina

Keyword(s):

Clinical Efficacy ◽

Breakthrough Pain ◽

Systemic Exposure ◽

Pharmacokinetic Profile ◽

Tolerability Profile ◽

Onset Of Action ◽

Patients With Cancer ◽

Fentanyl Buccal Tablet ◽

Buccal Tablet ◽

Buccal Absorption

The treatment of breakthrough pain (BTP), a transitory exacerbation of pain that occurs on a background of otherwise-controlled, persistent pain, requires an opioid formulation and/or method of administration that can provide rapid and extensive systemic exposure. Fentanyl buccal tablet (FBT; FENTORA®, Cephalon, Inc.) employs OraVescent® drug delivery technology, which enhances the rate and extent of fentanyl absorption. OraVescent technology enhances the oral dissolution and buccal absorption of fentanyl, which facilitates rapid uptake of fentanyl into the bloodstream, reducing gastrointestinal absorption and minimizing extensive first-pass metabolism. The resulting pharmacokinetic profile of FBT is characterized by greater bioavailability and a higher early systemic exposure compared with the earlier oral transmucosal fentanyl citrate formulation. In clinical studies of opioid-tolerant patients with cancer-related and noncancer-related BTP, FBT has provided consistent and clinically relevant improvements in pain intensity and pain relief relative to placebo, with a safety and tolerability profile that is generally typical of that observed with other potent opioids. The pharmacokinetic properties of FBT allow for meaningful clinical efficacy, with an onset of action that closely matches the onset of BTP.

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