MORRISTOWN, N.J., Oct. 7, 2014 /PRNewswire/ -- As part of our
ongoing commitment to addiction medicine, Orexo US, Inc. (Orexo)
announced the launch of a Patient Assistance Program (PAP) for
ZUBSOLV® (buprenorphine and naloxone) sublingual tablet
(CIII). This program provides ZUBSOLV free of charge to eligible
opioid dependent patients in need.
At this time, 1,000 patients who meet the program eligibility
criteria will be allowed to participate in the ZUBSOLV Patient
Assistance Program. Patients who meet income eligibility
requirements, including demonstrated household income not exceeding
three times the federal poverty level and no insurance coverage
that reimburses for ZUBSOLV, who are enrolled in the ZUBSOLV
Patient Assistance Program will be eligible to receive monthly
supplies of ZUBSOLV as prescribed by their physician at no charge.
Patients must demonstrate continued eligibility every six
months.
"We are proud to expand patient access to ZUBSOLV. Many patients
diagnosed and treated for opioid dependence may not have the means
or the discretionary income needed to pay for their ZUBSOLV
prescriptions," said Robert DeLuca,
R.Ph., President, Orexo US, Inc. "At Orexo, our commitment to
addiction medicine extends to ensuring eligible patients have
access to ZUBSOLV regardless of their financial status. The ZUBSOLV
PAP now allows patients in the program to receive ZUBSOLV free of
charge. Our intention is to expand the ZUBSOLV PAP as our business
in the U.S. continues to build."
The ZUBSOLV Patient Assistance Program is being administered by
the registered, charitable organization NeedyMeds. To learn more
about the ZUBSOLV Patient Assistance Program or to receive an
application to the program please log onto www.NeedyMeds.org or
call 1-888-236-4167.
For further information contact:
Robert DeLuca, President, Orexo US,
Inc.
Telephone: 1-973-936-6990
About the ZUBSOLV Patient Assistance Program
The
ZUBSOLV Patient Assistance Program (PAP) is administered for Orexo
US, Inc. by NeedyMeds, a national, registered charitable
organization (501c3) that administers several pharmaceutical PAP
programs, and allows eligible patients who can't afford their
medication and do not have prescription coverage to receive ZUBSOLV
free of charge.
ZUBSOLV is dispensed directly to patients accepted into the
ZUBSOLV PAP via a licensed mail-order pharmacy. 1,000 eligible
patients can be enrolled in this program at any one time.
Additional eligible patients will be added to a waiting list once
the program has reached capacity.
In order to be eligible to participate in the ZUBSOLV PAP,
patients must be 18-years of age or older, have a valid
prescription for ZUBSOLV 5.7mg/1.4mg (buprenorphine/naloxone)
sublingual tablets prescribed by a qualified physician with a DEA
"X" number for the maintenance treatment of opioid dependence, have
a household income below 300 percent of the federal poverty level
(FPL), have no other insurance coverage that pays for their ZUBSOLV
prescription, and be one of 1,000 eligible patients to enroll and
be accepted; any remaining, eligible patients will be placed on a
waiting list.
Patients can download an application on www.NeedyMeds.org or
call 1-888-236-4167 to receive an application via mail.
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.
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.
About NeedyMeds
NeedyMeds, a national nonprofit, is a
comprehensive and reliable source of information on assistance
programs available for people having difficulties paying for their
medications or health care. The website (http://www.needymeds.org)
is visited by approximately 10,000 people each workday. NeedyMeds'
information is always free, easy to access, and updated regularly.
Unlike similar sites, NeedyMeds requires no registration and
gathers no identifiable information on site visitors.
SOURCE Orexo US, Inc.