ProStrakan announces FDA approval for Transmucosal Immediate Release Fentanyl REMS Access program

Dec 31 2011

ProStrakan, Inc., a subsidiary of Kyowa Hakko Kirin Co. Ltd. (KHK), and an international specialty pharmaceutical company, today announces that the U.S. Food and Drug Administration (FDA) has approved the TIRF (Transmucosal Immediate Release Fentanyl) REMS (Risk Evaluation and Mitigation Strategy) Access program. This new REMS is a single shared system for all TIRF products, including ABSTRAL^® (fentanyl) sublingual tablets, an opioid analgesic used in the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

The goals of the TIRF REMS Access program are to mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors by:

• Prescribing and dispensing TIRF medicines only to appropriate patients, which includes use only in opioid-tolerant patients.
• Preventing inappropriate conversion between fentanyl products.
• Preventing accidental exposure to children and others for whom it was not prescribed.
• Educating prescribers, pharmacists and patients on the potential for misuse, abuse, addiction and overdose of TIRF medicines.

TIRF products are available only through REMS programs, which require enrollment by prescribers, their patients, pharmacies and distributors. Today, TIRF manufacturers have separate REMS programs and a health care provider and pharmacy must enroll in multiple REMS programs, corresponding to the TIRF product they choose to prescribe or dispense.  The new shared REMS – modeled after the program created for ABSTRAL - will go live in March 2012; at that time, prescribers, pharmacies, patients, and distributors may all be enrolled in a single program for these products. All stakeholders currently enrolled 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. 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.