MORRISTOWN, N.J., March 6, 2015 /PRNewswire/ -- Orexo US, Inc.
(Orexo) announced that following U.S. Food and Drug Administration
(FDA) approval, the new 8.6mg/2.1mg dosage strength of
ZUBSOLV® is now available. This approval is
based on the supplemental New Drug Application Orexo submitted to
the FDA on December 13, 2013. ZUBSOLV
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. ZUBSOLV sublingual
tablets deliver a greater proportion of active ingredient to the
bloodstream than other older sublingual buprenorphine/naloxone
products, allowing patients to use a lower strength thereby
reducing the amount of available drug for potential misuse. The new
dosage strength complements the existing strengths of 5.7 mg/1.4 mg
and 1.4 mg/0.36 mg tablets and may enable patients to receive their
optimal dose in just one tablet.
"Orexo is committed to partnering with healthcare providers and
helping patients effectively manage their disease and understands
the importance of expanding available treatments for those in
need," said Robert DeLuca, R.Ph.,
President, Orexo. "Treatment plans are typically tailored based on
a patient's needs and the approval and launch of the additional
ZUBSOLV 8.6/2.1mg tablet improves the ability for physicians and
patients to individualize treatment plans, helping patients on
their road to recovery."
For further information contact:
Robert DeLuca, President, Orexo US, Inc.
Telephone: 1-973-993-4866
About ZUBSOLV
ZUBSOLV sublingual tablets 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 tests
should be monitored before and during treatment. Children who take
ZUBSOLV sublingual tablets can have severe, possibly fatal,
respiratory depression. Emergency medical care is critical. 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.
ZUBSOLV is a maintenance medication for adults with opioid
dependence and should be used as part of a complete treatment plan
that also includes counseling and behavioral therapy. ZUBSOLV
delivers a comparable concentration of active medication to
previously approved buprenorphine/naloxone sublingual
tablets.1 In a U.S. study of 758 people with opioid
dependence, ZUBSOLV demonstrated comparable retention compared to
Suboxone film at Day 15 and in patients who experienced both
Suboxone film & ZUBSOLV, more than 70% preferred the advanced
formula attributes of ZUBSOLV (menthol flavor, easy to take and
mouthfeel).2
Further information on ZUBSOLV can be found at www.zubsolv.com.
Important Safety Information
Contraindications
- ZUBSOLV sublingual tablet should not be used by patients
hypersensitive to buprenorphine or naloxone, as serious adverse
reactions, including anaphylactic shock, have been reported
Warnings and Precautions
- 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. Multiple refills
should not be prescribed early in treatment or without appropriate
patient follow-up visits
- ZUBSOLV sublingual tablet can cause serious, life-threatening,
respiratory depression and death, particularly when taken by the
intravenous (IV) route in combination with benzodiazepines or other
central nervous system (CNS) depressants (eg, sedatives,
tranquilizers, or alcohol). Patients should be warned against
self-administration or misuse of these combinations
- Not recommended for initiation of treatment (induction) in
patients with moderate hepatic impairment due to the increased risk
of precipitated withdrawal. However, buprenorphine/naloxone
products may be used with caution for maintenance treatment in
patients with moderate hepatic impairment who have initiated
treatment on a buprenorphine product without naloxone. However,
patients should be carefully monitored and consideration given to
the possibility of naloxone interfering with buprenorphine's
efficacy.
- ZUBSOLV sublingual tablet is not recommended in patients with
severe hepatic impairment
- Dose reduction of CNS depressants, ZUBSOLV sublingual tablet,
or both should be considered in situations of concomitant
prescription
- Children who take ZUBSOLV sublingual tablet can have severe,
possibly fatal, respiratory depression Intravenous misuse or taking
ZUBSOLV sublingual tablet before the effects of full-agonist
opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone)
have subsided is likely to cause opioid withdrawal syndrome
- Neonatal withdrawal has been reported following use of
buprenorphine by the mother during pregnancy
- ZUBSOLV sublingual tablet is not appropriate as an analgesic.
There have been reported deaths of opioid-naive individuals who
received a 2-mg sublingual dose of buprenorphine
Use in Specific Populations
- Pregnancy: Based on animal data, buprenorphine may cause fetal
harm. Use of ZUBSOLV sublingual tablet in pregnant women or during
breastfeeding should only be considered if the potential benefit
justifies the potential risk.
- Nursing mothers: Caution should be exercised when
buprenorphine-containing products are administered to a nursing
woman. The safety of buprenorphine/naloxone in breastfeeding has
not been established
- Not recommended in patients with severe hepatic impairment and
may not be appropriate for patients with moderate hepatic
impairment.
Adverse Reactions
- 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
- This is not a complete list of potential adverse events
associated with buprenorphine/naloxone sublingual tablets. Please
see full Prescribing Information for a complete list
- To report an adverse event associated with taking ZUBSOLV
sublingual tablet, please call 1-888-ZUBSOLV (1-888-982-7658). You
are encouraged to report adverse events of prescription drugs to
the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088
Please see Full Prescribing Information and Medication Guide
for ZUBSOLV.
About Orexo US, Inc.
Orexo US, 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 a specialty pharma company with commercial
operations in the United States
and R&D in Sweden developing
improved treatments using proprietary drug delivery technology and
commercial operations in the United
States. The company is commercializing its proprietary
product, ZUBSOLV, for maintenance treatment of opioid dependence,
in the United States. ZUBSOLV is a
novel formulation of buprenorphine and naloxone using Orexo's
extensive knowledge in sublingual technologies. Orexo has a
portfolio of two approved and revenue generating products currently
marketed under license in the EU and US. Orexo AB, with its
headquarters in Sweden, is listed
on NASDAQ OMX Stockholm Exchange and its American Depositary
Receipts (ADRs) trade on the OTCQX marketplace in the U.S. under
the symbol, "ORXOY". The largest shareholders are Novo A/S and
HealthCap.
For information about Orexo, please visit www.orexo.com.
Suboxone is a registered trademark of Reckitt Benckiser
Healthcare (UK) Ltd.
- Fischer A, Jonsson M, Hjelmstrom P. Pharmaceutical and
pharmacokinetic characterization of a novel sublingual
buprenorphine/naloxone tablet formulation in healthy volunteers.
Drug Dev Ind Pharm. 2013;1-6. DOI:
10.3109/03639045.2013.846365.
- Data on file. Orexo US, Inc.
ZUB224B
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SOURCE Orexo U.S.