- 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.
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.
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