Orexo Launches ZUBSOLV Patient Assistance Program

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.