Galena Biopharma Launches Abstral(R) (fentanyl) Sublingual Tablets for the
Treatment of Breakthrough Cancer Pain
First Commercial Product for Galena Biopharma Available Nationwide
PORTLAND, Ore., Oct. 3, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma
(Nasdaq:GALE), a biopharmaceutical company developing and commercializing
innovative, targeted oncology treatments that address major unmet medical
needs to advance cancer care, today announced the official product launch of
Abstral^® (fentanyl) Sublingual Tablets in the United States. Abstral is a
sublingual (under the tongue) fentanyl tablet indicated 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. Galena acquired Abstral in March 2013 and
since that time has scaled its field commercial team, manufactured the drug
for commercial sale, secured broad access and reimbursement support from
commercial and federal health insurance entities, implemented a robust patient
assistance program, and developed a broad product distribution network.
Abstral can be prescribed by healthcare professionals and is available to
patients at all retail pharmacies nationwide.
"As an oncology company dedicated to improving patients' lives, we are
thrilled to introduce Abstral as our first commercial product and offer cancer
patients relief from their breakthrough pain," said Mark J. Ahn, President and
Chief Executive Officer."We believe Abstral delivers best in class
performance because it is simple to carry, simple to use, and requires no
speacial handling or disposal.We have a commercial team of highly dedicated,
patient-focused professionals with experience in both pain and oncology who
have helped us reach this tremendous milestone for Galena. I look forward to
reporting our continued progress later this year."
Breakthrough cancer pain is defined as a transient exacerbation of pain that
occurs either spontaneously, or in relation to a specific predictable or
unpredictable trigger, despite relatively stable and adequately controlled
background pain.Breakthrough cancer pain occurs in the majority of patients
who are already receiving chronic, long-acting opioid pain management and yet
have episodes of severe tumor- and treatment-related cancer pain.Breakthrough
pain occurs frequently in these patients, particularly as they try to conduct
normal daily activities, with a mean number of episodes of 4 per day (range of
1-14 per day) and a median duration of 30 minutes (range of 1-240 minutes).
The wide range of time to relief of these severe pain episodes leads to high
levels of distress and impaired quality of life experienced by patients.
About Abstral® (fentanyl) Sublingual Tablets
Abstral® (fentanyl) Sublingual Tablets are an important treatment option for
inadequately controlled breakthrough cancer pain which impact 40%-80% of
cancer patients. Abstral is approved by the U.S. Food and Drug Administration,
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.
Important Abstral Safety Information
*There is a risk of respiratory depression, medication errors, and abuse
potential with the use of Abstral.See full prescribing information for
important complete black-box warning.
*Due to the risk of fatal respiratory depression, ABSTRAL is
contraindicated in opioid non-tolerant patients and in management of acute
or postoperative pain, including headache/migraines.
*Keep out of reach of children.
*Use with CYP3A4 inhibitors may cause fatal respiratory depression.
*When prescribing, do not convert patients on a mcg per mcg basis from any
other oral transmucosal fentanyl product to ABSTRAL.
*When dispensing, do not substitute with any other fentanyl products.
*Contains fentanyl, a Schedule II controlled substance with abuse liability
similar to other opioid analgesics.
*ABSTRAL is available only through a restricted program called the TIRF
(Transmucosal Immediate Release Fentanyl) REMS (Risk Evaluation and
Mitigation Strategy)Access program. Outpatients, healthcare professionals
who prescribe to outpatients, pharmacies, and distributors are required to
enroll in the program.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based
biopharmaceutical company developing and commercializing innovative, targeted
oncology treatments that address major unmet medical needs to advance cancer
care.For more information visit www.galenabiopharma.com.
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995.Such statements include,
but are not limited to, statements about the progress of the commercialization
of Abstral® and development of Galena's product candidates, including patient
enrollment in our clinical trials, as well as statements about our
expectations for our commercial success, plans and prospects. These
forward-looking statements are subject to a number of risks, uncertainties and
assumptions, including those 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 quarter ended June 30, 2013 filed 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.
CONTACT: Remy Bernarda
Senior Director, Communications
Galena Biopharma, Inc.
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