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FDA Approves Shared REMS (Risk Evaluation and Mitigation Strategy) Program for all TIRF (Transmucosal Immediate Release Fentanyl) Pain Treatments
Date:12/30/2011

in any of the individual REMS programs will be automatically enrolled in the shared system in March 2012.

"ProStrakan is thrilled to see our hard work and the work of the industry working group culminate in this approval," said Anthony G. Oladipo, Pharm.D., M.P.H, BCPS, VP Global Head of Drug Safety & Risk Management, ProStrakan, Inc. "We are fully committed to patient safety and pleased to help the FDA achieve its goal of assuring appropriate use of pain medications."

ProStrakan's product, ABSTRAL is the first and only rapidly-disintegrating tablet placed under the tongue for breakthrough cancer pain. In January 7, 2011 it was approved by the FDA for use 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 provides a simple, patient-friendly and efficacious treatment option for cancer patients with breakthrough pain, which can be incapacitating, limiting patients' ability to participate in daily activities," said John Higgins, General Manager, ProStrakan, Inc. "Now, all TIRF products will be administered equally through a single REMS, making the process simpler for prescribers, patients, pharmacists, and distributors."

Breakthrough cancer pain, common in up to two-thirds of people with cancer-related pain, affects a patient's quality of life, including physical and emotional health, interpersonal relationships and the ability to engage in certain activities. Breakthrough pain (BTP) is described as severe pain that "breaks through" the patient's round-the-clock pain medicine.[i] 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.

For more information on ABSTRAL, please visit www.ABSTRAL.com. For more information on the TIRF REMS Access program, please visit '/>"/>

SOURCE ProStrakan, Inc.
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