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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.

BEDMINSTER, N.J., April 4, 2011 /PRNewswire/ -- ProStrakan Group plc (LSE: PSK) today announced the availability of ABSTRAL ® (fentanyl) sublingual tablets as the first rapidly-disintegrating tablet placed under the tongue for breakthrough cancer pain. The U.S. Food and Drug Administration (F.D.A.) approved ABSTRAL, an opioid analgesic, in January 2011 specifically for the management of breakthrough pain in cancer patients, 18 years of age or older, who are already receiving, and who are tolerant to, opioid therapy for their underlying persistent cancer pain . ABSTRAL is available only through an F.D.A mandated program, ABSTRAL REMS (Risk Evaluation and Mitigation Strategy).

Breakthrough cancer pain, common in one-half to two-thirds of people with cancer-related pain, affects a patient's quality of life including physical and emotional health, interpersonal relationships and ability to engage in certain activities. Breakthrough pain (BTP) is described as severe pain that "breaks through" regular pain medicine.(1) Opioids are among the most potent and effective analgesics, or medicines given to reduce pain, but unfortunately are also some of the most misused and abused medicines.

"Breakthrough pain in cancer patients is very serious and debilitating. As we aim to manage our patients' level of pain, there are often barriers that limit the effectiveness of opioid treatments, including route of administration and poor access to currently available treatments," said Srinivas Nalamachu, M.D., ABSTRAL Principal Investigator, International Clinical Research Institute, Inc., and Kansas City University of Medicine and Biosciences. "With ABSTRAL and the ABSTRAL REMS program, we have the ability to offer patients a proven opioid pain management therapy that is fast acting and easy to use, while also minimizing risks for abuse, addiction, overdose or diversion through a stringent F.D.A.-Approved REMS."

ABSTRAL is the only available analgesic that disintegrates quickly under the tongue. It offers an alternative therapeutic choice to patients and clinicians with a simple, patient-friendly and predictable way of delivering fentanyl transmucosally, while retaining the individualized dose titration aspects required for optimal treatment of breakthrough pain.

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