AUSTIN, TX—In a study presented at the American Pain Society's 30th Annual Scientific Meeting, fentanyl buccal tablet (FBT) was shown to be more effective than traditional short-acting opioids (SAO) for the management of breakthrough pain (BTP) in opioid-tolerant patients.
Lynn Webster, MD, FACPM, FASAM, and colleagues from Cephalon (who supported the study), re-randomized opioid-tolerant adults with BTP who had previously completed a randomized, double-blind, active-controlled, crossover study to FBT or any traditional SAO for 12 weeks of open-label treatment.
After the treatment period, patients and clinicians completed a seven-point scale (from very much worsened to very much improved) and 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).
A total of 130 patients were randomized to receive treatment (FBT: n=65, mean age 51.8 years, female 62%, Caucasian 94%; SAO: n=65, mean age 49.4 years, female 55%, Caucasian 88%). The majority of patients randomized to an SAO received oxycodone (68% [n=44]) for their BTP medication.
For the PAF, more patients receiving FBT than those receiving SAO reported improvement in 11 of 12 areas of functioning (P<0.05 for seven 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 six areas of functioning) with FBT than with SAO, including improvement in enjoyment of life (68% vs. 38%; P<0.001). Responses to the PGIC and CGIC also favored FBT over 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 the treatment groups and were standard for opioids.
Dr. Webster concluded that following 12 weeks of open-label treatment, patients and clinicians reported consistently better efficacy, including functional improvement, with fentanyl buccal tablet than with traditional SAOs in opioid-tolerant patients with breakthrough pain.