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ABSTRAL® (fentanyl) Sublingual Tablets CII, First-in-class, Sublingual, Immediate Release Opioid for Managing Breakthrough Cancer Pain, Now Available in the U.S.
Date:4/4/2011

l for misuse, abuse, addiction, and overdose.

For more information on ABSTRAL and the ABSTRAL REMS program, please visit www.ABSTRAL.com and www.ABSTRALREMS.com or call 1-888-ABSTRAL (1-888-227-8725).

ABSTRAL Clinical Data

A double-blind, placebo-controlled, crossover study evaluated the clinical efficacy of ABSTRAL versus placebo in the treatment of opioid tolerant, adult cancer patients with BTP.

Open-label titration identified a dose of ABSTRAL in which a patient obtained adequate pain relief with tolerable side effects, within the range of 100 mcg to 800 mcg. In the double-blind efficacy study, patients who identified a successful dose were randomized to a sequence of 10 treatments; seven with ABSTRAL and three with placebo.

Of the 131 patients who entered the titration phase of the study, 78 (60 percent) achieved a successful dose during the titration phase. Sixty-six patients entered the double-blind phase and 60 completed the study. The dose of ABSTRAL was determined by titration starting at 100 mcg. The final titrated dose of ABSTRAL for breakthrough cancer pain was not predicted from the daily maintenance dose of opioid used to manage the persistent cancer pain. In a second open-label safety study using an identical titration regimen, 96 of 139 patients (69 percent) who entered the study titrated to a dose in which the patient obtained adequate pain relief with tolerable side effects during the titration phase.

Common adverse reactions associated with ABSTRAL include nausea, constipation, drowsiness and headache.

About ABSTRAL®

ABSTRAL® (fentanyl) sublingual tablets, a rapidly disintegrating sublingual tablet formulation of fentanyl citrate designed for oral transmucosal delivery, is approved in the U.S. for the management of breakthrough pain in cancer patients, 18 years of age
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SOURCE ProStrakan Group plc
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