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Orexo Enters an Exclusive Reimbursement Agreement with UnitedHealth Group and OptumRx for ZUBSOLV®

Uppsala, Sweden – March 12, 2014 – Orexo AB, the manufacturer of ZUBSOLV® (buprenorphine and naloxone) sublingual tablets (CIII), announced a multi-year agreement with UnitedHealth Group® and OptumRx® providing preferred coverage and reimbursement of ZUBSOLV®.

Under the agreement, ZUBSOLV will be given preferred, Tier 2 brand status on UnitedHealth Group commercial employer and individual formularies managed by OptumRx for the maintenance treatment of opioid dependence through June 30, 2014. Beginning on July 1, 2014 ZUBSOLV will become the only buprenorphine/naloxone combination product on all of UnitedHealth’s closed and highly managed health plan formularies, inclusive of all brand and generic formulations.

“Orexo’s mission is to increase access to medication-assisted treatment plans, help reduce relapse rates and improve successful patient outcomes – all critically important in the face of the growing opioid dependence epidemic in the US,” said Robert DeLuca, R.Ph., President, Orexo U.S., Inc. “Our long term strategic partnership with UnitedHealth Group and OptumRx enables us to assist a greater number of patients who are incorporating a treatment option such as ZUBSOLV into their recovery plans.”

“Orexo is dedicated to broadening the market access position for ZUBSOLV and this agreement with UnitedHealth Group and OptumRx is an important step in that direction. It is a major achievement and endorsement as health insurers with a firm control over their formularies recognize ZUBSOLV as the preferred buprenorphine/naloxone formulary product for the maintenance treatment of opioid dependence” said Nikolaj Sorensen, CEO and President of Orexo.

ZUBSOLV is an advanced sublingual tablet formulation for maintenance treatment of opioid dependence with high bioavailability, a fast dissolve time, small tablet size, and menthol flavor. The advanced formulation provided by ZUBSOLV was specifically designed to meet the needs expressed by patients. Meeting patient needs may have the potential to improve patient adherence, thus reducing relapse rates and improving successful patient outcomes. It is the only opioid dependence treatment option available in the highest level of child resistant, unit dose, F1 packaging, designed to reduce the chance of unintended pediatric exposure.

For further information, please contact:
Nikolaj Sorensen, President and CEO, Orexo AB
Tel: +46-703 50 78 88, E-mail:

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

About Orexo
Orexo is a specialty pharmaceutical company with commercial operations in the United States and R&D in Sweden developing improved treatments using proprietary drug delivery technology. The company is commercializing its proprietary product, ZUBSOLV® (buprenorphine and naloxone), in the United States for maintenance treatment of opioid dependence. ZUBSOLV is a novel sublingual 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, US and Japan. Orexo’s development expertise is within the area of reformulation technologies, and especially sublingual formulations. Orexo AB, with its headquarters in Sweden, is listed on NASDAQ-OMX. The largest shareholders are Novo A/S and HealthCap.
For information about Orexo, please visit

About Orexo U.S., Inc.
Orexo U.S., Inc. is a subsidiary to Orexo AB, a specialty pharmaceutical company. The subsidiary markets improved treatments for opioid dependence using proprietary drug delivery technology. To receive more information, please contact Orexo at 1-855-ZUBSOLV.

Source: Orexo