Long-term effectiveness and tolerability of sublingual fentanyl orally disintegrating tablet for the treatment of breakthrough cancer pain.

Background And Objectives: Breakthrough cancer pain (BTcP) is a transient exacerbation of cancer pain in patients with otherwise stable, persistent background pain. This study evaluated the long-term effectiveness and tolerability of sublingual fentanyl orally disintegrating tablet (sublingual fentanyl ODT), for the treatment of BTcP in opioid-tolerant patients with cancer.

Research Design And Methods: This was a non-randomized, open-label, multi-center, Phase III study conducted in opioid-tolerant patients (aged ≥17 years) with BTcP.

Sublingual administration of fentanyl to cancer patients is an effective treatment for breakthrough pain: results from a randomized phase II study.

In this study we evaluated the efficacy and tolerability of sublingual fentanyl (SLF) for breakthrough pain (BTP) in adult opioid-tolerant cancer patients. Patients received one dose of placebo, SLF 100, 200 and 400 microg in random order at four pain episodes. The primary efficacy endpoint was pain intensity difference (PID) from baseline.

Efficacy and long-term tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain.

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 randomized, placebo-controlled, multi-center, phase III trial, conducted in opioid-tolerant male and female patients (aged > or =17 years) with BTcP.