MORRISTOWN, N.J., Dec. 6, 2014 /PRNewswire/ -- Orexo US, Inc.
(Orexo) announced results from the ISTART/006 study, being
presented today at the 25th Annual Meeting and Symposium
of the American Academy of Addiction Psychiatry (AAAP) in
Aventura, Florida, USA. In the
study, ZUBSOLV® (buprenorphine and naloxone) sublingual
tablet (CIII) demonstrated comparable patient retention in
treatment at day 15 versus Suboxone® film. ZUBSOLV also
demonstrated no increased rate of withdrawal symptoms or opioid
cravings versus Suboxone film at day 15 and day 22. AAAP marks the
first time these data are presented in a peer-reviewed forum,
following the release of topline results in June 2014.
"We look forward to unveil these findings of the ISTART/006
study – the largest clinical trial ever conducted in the United States to assess
buprenorphine/naloxone for the treatment of opioid dependence –
reinforcing our dedication to advance research in leveraging
medication-assisted treatment for opioid dependence," said
Michael Sumner, M.D., Chief Medical
Officer, Orexo US, Inc. "Despite an average 26 to 32 percent lower
dose of buprenorphine in ZUBSOLV compared to that in Suboxone film
used, ZUBSOLV showed comparable efficacy to Suboxone film, which
may help reduce the potential for misuse."
ISTART Study Design & Outcomes
The ISTART study was a randomized, multicenter, non-inferiority
Phase 3 clinical trial designed to evaluate the efficacy of ZUBSOLV
compared with Suboxone film during stabilization of patients with
opioid dependence.
758 patients began the maintenance phase of the study with
either ZUBSOLV or Suboxone film. At day 15, ZUBSOLV patients
switched to Suboxone film and those taking Suboxone film switched
to ZUBSOLV.
The co-primary endpoint was retention in treatment at day 15. On
day 15, the number of patients who were retained in treatment were
similar across the ZUBSOLV and Suboxone film arms (74.9 percent
versus 74.4 percent, respectively, P=0.866).
Secondary endpoints included assessment of treatment effects on
opioid withdrawal symptoms for ZUBSOLV versus Suboxone film via
both the Clinical Opiate Withdrawal Scale (COWS) score and
Subjective Opiate Withdrawal Scale (SOWS), and opioid cravings via
the visual analogue scale (VAS). Reductions in opioid withdrawals
and opioid cravings were comparable between treatment groups.
The safety profile of ZUBSOLV was similar to that of Suboxone
film.
"I am pleased to present the data of the ISTART study at AAAP,
demonstrating ZUBSOLV is comparable to Suboxone film to treat
opioid dependence," said Erik
Gunderson, M.D., FASAM, Assistant Professor in the
Department of Psychiatry and Neurobehavioral Sciences and
Department of Medicine at the University of
Virginia, and principle investigator of the study.
Robert DeLuca R.Ph., President of
Orexo US, Inc. noted, "The ISTART/006 data and our presentation at
AAAP are another example of Orexo's continued commitment to both
advancing the treatment of opioid dependence and supporting the
patients who suffer from this disease as well as the healthcare
professionals who treat them."
For further information contact:
Robert DeLuca, President, Orexo US,
Inc.
Telephone:
1-973-936-6990
www.orexo.com/US
For a visual backgrounder on the ISTART/006 study,
visit:
http://origin-qps.onstreammedia.com/origin/multivu_archive/ENR/ZUBSOLV_One-Pager.pdf
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 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.
Further information on ZUBSOLV can be found at
www.zubsolv.com.
Important Safety Information
- Keep ZUBSOLV in a secure place away from children. If a
child accidentally takes ZUBSOLV, this is a medical emergency and
can result in death. Get emergency help right away
- ZUBSOLV can cause serious and life-threatening breathing
problems. Call your doctor right away or get emergency help if (a)
you feel faint, dizzy, or confused; (b) your breathing gets much
slower than is normal for you; (c) you feel sleepy and
uncoordinated; (d) you have blurred vision; (e) you have slurred
speech; (f) you cannot think well or clearly; or (g) you have
slowed reflexes and breathing. In an emergency, have family members
tell the emergency department staff that you are physically
dependent on an opioid and are being treated with ZUBSOLV
- The most common side effects of ZUBSOLV include: headache, drug
withdrawal syndrome, nausea, decrease in sleep (insomnia),
vomiting, pain, increased sweating, swelling of the extremities,
and constipation. Tell your doctor about any side effect that
bothers you or that does not go away
- Do not switch from ZUBSOLV to other medicines that contain
buprenorphine without talking with your doctor. The amount of
buprenorphine in a dose of ZUBSOLV is not the same as the amount of
buprenorphine in other medicines that contain buprenorphine. Your
doctor will prescribe a starting dose of buprenorphine that may be
different than other buprenorphine-containing medicines you may
have been taking
- ZUBSOLV contains an opioid that can cause physical dependence.
Do not stop taking ZUBSOLV without talking to your doctor. You
could become sick with uncomfortable withdrawal signs and symptoms
because your body has become used to this medicine. Physical
dependence is not the same as drug addiction. ZUBSOLV is not for
occasional or "as needed" use
- An overdose, and even death, can happen if you take
benzodiazepines, sedatives, tranquilizers, or alcohol while using
ZUBSOLV. Ask your doctor what you should do if you are taking one
of these. You should not drink alcohol while taking ZUBSOLV, as
this can lead to loss of consciousness or even death
- Do not inject ("shoot-up") ZUBSOLV. Injecting ZUBSOLV may cause
life-threatening infections and other serious health problems.
Injecting ZUBSOLV may cause serious withdrawal symptoms such as
pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and
cravings
- Before taking ZUBSOLV, tell your doctor about all the medicines
you take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements
- Before taking ZUBSOLV, tell your doctor if you are pregnant or
plan to become pregnant. It is not known if ZUBSOLV will harm your
unborn baby. If you take ZUBSOLV while pregnant, your baby may have
symptoms of withdrawal at birth. Talk to your doctor if you are
pregnant or plan to become pregnant
- Before taking ZUBSOLV, tell your doctor if you are
breastfeeding or plan to breastfeed. ZUBSOLV can pass into your
breast milk and may harm the baby. Talk to your doctor about the
best way to feed your baby if you take ZUBSOLV. Monitor your baby
for increased sleepiness and breathing problems
- Do not drive, operate heavy machinery, or perform any other
dangerous activities until you know how ZUBSOLV affects you.
Buprenorphine can cause drowsiness and slow reaction times. This
may happen more often in the first few weeks of treatment when your
dose is being changed, but can also happen if you drink alcohol or
take other sedative drugs when you take ZUBSOLV
- ZUBSOLV is a controlled substance (CIII) because it contains
buprenorphine, which can be a target for people who abuse
prescription medicines or street drugs. Keep your ZUBSOLV in a safe
place to protect it from theft. Never give your ZUBSOLV to anyone
else; it can cause death or harm them. Selling or giving away this
medicine is against the law
- To report negative side effects associated with taking ZUBSOLV,
please call 1-888-982-7658. You are encouraged to report negative
side effects 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.
Suboxone is a registered trademark of Reckitt Benckiser (UK)
Ltd.
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 1-888-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.
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SOURCE Orexo US, Inc.