In the news release, Zubsolv® Now Available in the U.S. for the
Maintenance Treatment of Opioid Dependence, issued 16-Sep-2013 by Orexo U.S. over PR Newswire, we
are advised by the company that the phone number in the fifth
paragraph and the Orexo U.S., Inc. boilerplate, should read
"1-855-ZUBSOLV" rather than "1-888-ZUBSOLV" as originally issued
inadvertently. The complete, corrected release follows:
Zubsolv® Now Available in the U.S. for the Maintenance Treatment of
Opioid Dependence Zubsolv is a new, advanced formulation treatment
option for opioid dependent patients that provides higher
bioavailability, fast dissolve time, smaller tablet size and a new
menthol flavor
NEW YORK, Sept. 16, 2013 /PRNewswire/ -- Orexo U.S.
announced today that Zubsolv (buprenorphine and naloxone)
sublingual tablets (CIII) are commercially available in pharmacies
across the United States. In
July 2013, Zubsolv received approval
from the U.S. Food and Drug Administration (FDA) for the
maintenance treatment of opioid dependence. Zubsolv should be used
as part of a complete treatment plan, including counseling and
psychosocial support.
The most effective treatment for opioid dependence is a
combination of pharmacological therapy and psychological
counseling.[i],[ii] Opioid dependence is a disease, like
hypertension, schizophrenia or diabetes, and affects nearly 5
million people across the United
States.[iii],[iv],[v] Although it is a treatable
condition, even among those diagnosed as opioid dependent, 60% do
not receive treatment.[iii] Every year thousands
of patients continue to misuse opioids rather than risk the stigma
of public exposure by receiving treatment.[vi]
The higher bioavailability of Zubsolv allows for a lower dose of
buprenorphine being administered which, in combination with the
naloxone component, reduces the amount of available drug and the
likelihood of potential misuse and diversion. Zubsolv is the only
opioid dependence treatment available today in the highest level of
child resistant packaging (F1), and each Zubsolv tablet is supplied
in individual unit-dose blister packages, reducing the chance of
unintended pediatric exposure
"Orexo is committed to advance the treatment for patients
suffering from opioid dependence. Zubsolv was specifically designed
to address many of the unmet needs expressed by patients being
treated for opioid dependence," said Robert
DeLuca, R.Ph., President, Orexo U.S. "In an open-label,
crossover study in 28 subjects, we found that ninety-six percent
preferred the menthol taste of Zubsolv over the most commonly
prescribed formulation of buprenorphine/naloxone."
In addition to the commercial launch of Zubsolv, Orexo issued
today the Time and Taste Challenge, inviting patients and
prescribers to register to receive demonstration placebo tablets to
experience the taste and dissolve time for this new advanced
formulation. The placebo tablets are for demonstration purposes
only and do not contain active medication. Register for the Time
and Taste Challenge at www.zubsolv.com or by calling
1-855-ZUBSOLV.
Orexo is also premiering RISE™, a 24/7,
real-time, customizable support program informed by patients in
recovery. The HIPPA compliant program provides information about
opioid dependence and resources to help facilitate a two-way
conversation between patients and their chosen mentor network which
may also include their doctor and counselor. The program is mobile
enabled, allowing for access anytime, anywhere. Visit
www.rise-us.com to learn more about the RISE program.
Opioid dependence greatly impacts the U.S. economy, with about
$56 billion spent on the disease per
year.[vii] In addition, the average healthcare cost per
patient with opioid dependence is eight times higher compared to
nondependent patients.[viii] There also is a great
impact on human life, with almost 17,000 deaths from opioid pain
relievers in the U.S. every year.[ix]
Orexo also announced today that it has established a sponsored
level 1 American Depositary Receipt (ADR) program in the United States. Orexo's ADR program trades
in the US over-the-counter (OTC) market, under the symbol ORXOY,
with each ADR comprised of 1 ordinary share. Orexo's ordinary
shares are listed on the NASDAQ OMX Stockholm Exchange under the
symbol ORX.
For further information contact:
Robert DeLuca, President, Orexo U.S.,
Inc.
Telephone: 1-973-993-4866
About Opioid Dependence
Opioid dependence is a chronic
relapsing disorder like diabetes or high blood pressure, and can
develop as a result of either legitimate use or misuse of opioids.
Frequent opioid use physically changes the brain, so that the brain
starts to think that it needs opioids to function normally.
Subsequently, people with opioid dependence experience cravings and
symptoms of withdrawal when the effects of opioids begin to wear
off.
About Zubsolv
Zubsolv® (buprenorphine and
naloxone) sublingual tablet (CIII) is indicated for the maintenance
treatment of opioid dependence and should be used as part of a
comprehensive treatment plan, which includes counseling and
psychosocial support. Treatment should be initiated under the
direction of physicians who are certified under the Drug Addiction
Treatment Act of 2000, and who have been assigned a unique
identification number ("X" number).
Zubsolv sublingual tablet can be abused in a manner similar to
other opioids, legal or illicit. Clinical monitoring appropriate to
the patient's level of stability is essential. Liver function
should be monitored before and during treatment.
Children who take Zubsolv sublingual tablet can have severe,
possibly fatal, respiratory depression. Emergency medical care is
critical. Zubsolv is the only opioid dependence treatment that is
available in the highest level (F1) child resistant, individual
unit-dose packaging, thereby reducing the chance of unintended
pediatric exposure. Keep Zubsolv sublingual tablets out of the
sight and reach of children.
Adverse events commonly observed with the sublingual
administration of buprenorphine/naloxone sublingual tablets during
clinical trials and post-marketing experience are headache, nausea,
vomiting, hyperhidrosis, constipation, signs and symptoms of
withdrawal, insomnia, pain and peripheral edema.
About Orexo U.S., Inc.
Orexo U.S., Inc. is an emerging
specialty pharmaceutical company marketing improved treatments for
opioid dependence using proprietary drug delivery technology. To
receive more information please contact Orexo at 1-855-Zubsolv.
About Orexo AB
Orexo AB is an emerging specialty
pharma company with commercial operations in the United States and R&D in Sweden developing improved treatments using
proprietary drug delivery technology. Orexo's expertise is within
the area of reformulation technologies and especially sublingual
formulations. The company has a portfolio of revenue-generating
U.S. and EU approved products currently marketed under license and
a pipeline of several reformulations of approved compounds for
areas of unmet medical need. Orexo also has collaboration projects
with several international pharmaceutical companies. Orexo AB, with
its headquarters in Sweden, is
listed on NASDAQ-OMX. The largest shareholders are Novo A/S and
HealthCap.
Orexo's proprietary technology relating to Zubsolv is protected
by patents and patent applications in the U.S. and other markets
worldwide. Projected expiry dates for this IP range from 2019 to
2032.
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[i]
American Family Physician. "Buprenorphine: Effective Treatment of
Opioid Addiction Starts in the Office." May 2006.
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[ii]
National Institute on Drug Abuse. "Principles of Drug Addiction
Treatment: A Research-Based Guide (Third Edition)." December
2012.
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[iii]
Science & Practice Perspectives. "The Neurobiology of Opioid
Dependence: Implications for Treatment." July 2002.
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[iv]
Cleveland Clinic Journal of Medicine. "Buprenorphine maintenance: A
new treatment for opioid dependence." July 2007.
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[v]
Substance Abuse and Mental Health Services Administration, Results
from the 2010 National Survey on Drug Use and Health: Summary of
National Findings, NSDUH Series H-41, HHS Publication No. (SMA)
11-4658. Rockville, MD: Substance Abuse and Mental Health Services
Administration, 2011.
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[vi]
Journal of Managed Care Pharmacy. "Empirical view of Opioid
Dependence." February 2010.
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[vii] Pain
Medicine. "Societal Costs of Prescription Opioid Abuse, Dependence,
and Misuse in the United States." April 2011.
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[viii]
Journal of Managed Care Pharmacy. "Direct Costs of Opioid Abuse in
an Insured Population in the United States." July/August
2005.
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[ix]
Centers for Disease Control and Prevention. Prescription Painkiller
Overdoses. Accessed July 3, 2013.
http://www.cdc.gov/VitalSigns/pdf/2013-07-vitalsigns.pdf.
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SOURCE Orexo U.S.
