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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

e 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.

ABSTRAL REMS Program

ABSTRAL is the first and only sublingual, transmucosal, immediate release fentanyl product to be available through a class-wide Risk Evaluation and Mitigation Strategy (REMS) program mandated and approved by the F.D.A., which requires health care professionals and pharmacies that prescribe or distribute ABSTRAL to patients in the community setting to enroll in the program. Starting in April, ABSTRAL will be available in those chain and independent pharmacies that have enrolled in the ABSTRAL REMS program.

"The improper use of opioid medications is a serious issue with potentially devastating consequences for patients and the broader community. Through the ABSTRAL REMS program, ProStrakan has committed to providing necessary education around the benefits and risks of opioid pain management," said Abid Karim, President of Global Commercial Operations. "ProStrakan strives to provide access to safe and effective treatment options to address the unmet needs of cancer patients and the healthcare community."

The goal of the ABSTRAL REMS program is to provide effective access to ABSTRAL while mitigating the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors by:

  • Prescribing and dispensing ABSTRAL 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 potentia
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SOURCE ProStrakan Group plc
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