- Abstral® (fentanyl) Sublingual Tablets are an important new treatment option for inadequately controlled breakthrough cancer pain (BTcP) which impacts the majority of cancer patients at some point in their care.
- Abstral, the first and only sublingual fentanyl tablet for BTcP, TIRF REMS serves as model program.
LAKE OSWEGO, Ore., May 9, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, presented information on the development of a Transmucosal Immediate Release Fentanyl (TIRF) REMS program at the American Pain Society 32nd Annual Scientific Meeting. The event is being held May 8-11, 2013 at the Ernest N. Morial Convention Center in New Orleans, Louisiana.
The poster presentation entitled: "Development of a Federally Mandated Risk Evaluation and Mitigation Strategy (REMS) for Transmucosal Immediate-Release Fentanyl Products" describes the development and implementation of the now fully implemented TIRF REMS program for this important class of drug. The poster concluded that the TIRF REMS program is an important step toward the Food and Drug Administration Amendments Act (FDAAA) goals to reduce misuse, abuse, addiction, overdose, and medication-related errors. The shared TIRF REMS program streamlines the process to safely provide appropriate patients with various forms of TIRF medications, and points out that the goals of the TIRF REMS program need to be balanced against the potential for untreated or poorly treated pain. The complex nature of these goals requires collaboration amongst prescribers, pharmacies, distributors, and patients to achieve optimal success.
"Abstral is a significant advance for patients with breakthrough cancer pain and the TIRF REMS program is an essential element to prescribing Abstral® to ensure that patients are safely and effectively treated," stated Mark J. Ahn, Ph.D., Galena's President and Chief Executive Officer. "Abstral's sublingual TIRF REMS program served as a model for the current shared TIRF REMS, and we look forward to launching our product in the U.S. this year."
The presentation also concluded that the shared TIRF REMS program aims to minimize risk by limiting the dispensing of medication to appropriate patients, preventing inappropriate conversion between fentanyl products, avoiding accidental exposure, and providing education on medication-related risks.
"The TIRF REMS program provides my practice with the ability to choose the appropriate product based on my patient's needs, and Abstral is an essential drug as part of this arsenal to effectively treat my cancer patients with breakthrough pain," added Srinivas R. Nalamachu, M.D., International Clinical Research Institute, Overland Park, Kansas.
About Abstral® (fentanyl) Sublingual Tablets
Abstral® (fentanyl) Sublingual Tablets are an important new treatment option for inadequately controlled breakthrough cancer pain (BTcP) which impact 40%-80% of cancer patients. Abstral is approved by the FDA, and is a sublingual (under the tongue) fentanyl tablet indicated only for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. The innovative Abstral formulation delivers the analgesic power and increased bioavailability of micronized fentanyl in a more convenient sublingual tablet which rapidly dissolves under the tongue in seconds, provides rapid relief of breakthrough pain in minutes, and matches the duration of the entire pain episode.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based biopharmaceutical company developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information please visit us at www.galenabiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 relating to Galena's expectations for commercialization of Abstral®. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including the possibility that Galena's commercialization of Abstral may be delayed or prove unsuccessful. Galena's business and operations and the development of its product candidates also are subject to the risks and uncertainties identified under "Risk Factors" in Galena's Annual Report on Form 10-K for the year ended December 31, 2012 and Quarterly Report on Form 10-Q for the three months ended March 31, 2013 and in other filings Galena periodically makes with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.