About Abstral® (fentanyl) Sublingual TabletsAbstral® is an important new treatment option for inadequately controlled breakthrough cancer pain (BTcP) in opioid-tolerant cancer patients. The innovative Abstral formulation delivers the analgesic power of fentanyl in a convenient and easy to use sublingual tablet, which dissolves under the tongue within seconds. Abstral provides rapid relief of BTcP, predictable dosing, and is convenient and easy to use. Abstral was approved by the FDA in 2011. Abstral is a sublingual (under the tongue) fentanyl tablet indicated only for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. Abstral was evaluated in 311 opioid-tolerant cancer patients with breakthrough pain. Of these patients, 270 were treated in multiple-dose studies. The duration of therapy for patients in multiple-dose studies ranged from 1-405 days with an average duration of 131 days and with 44 patients treated for at least 12 months. Formulated as rapidly disintegrating muco-adhesive sublingual tablets, Abstral is highly lipophilic with the fentanyl release from the tablet almost instantly. It is highly potent, crossing the blood-brain barrier rapidly, avoiding first-pass metabolism by the liver enzymes, and therefore offering high bioavailability. Moreover, the time-effect profile of Abstral closely matches the time-intensity profile of breakthrough cancer pain episodes; and the pharmacokinetics of Abstral have been shown to be dose-proportional over the dose range of 100µg to 800µg. Common adverse reactions include nausea, constipation, drowsiness and headache. Serious adverse events, including deaths, have been reported in patients with other immediate-release transmucosal fentanyl products and occurred as a result of improper patient selection and/or improper dosing. Abstral is available only through the transmucosal immediate-release fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction and overdose. The FDA has standardized key components of the REMS program to facilitate the adoption of a single shared system. These components include the REMS document, the Patient-Prescriber Agreement, and the enrollment form.