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Orexo Release: Zubsolv® Now Available in the U.S. for the Maintenance Treatment of Opioid Dependence



9/16/2013 10:14:52 AM

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NEW YORK, Sept. 16, 2013 /PRNewswire/ -- Orexo U.S. announced today that Zubsolv (buprenorphine and naloxone) sublingual tablets (CIII) are commercially available in pharmacies across the United States. In July 2013, Zubsolv received approval from the U.S. Food and Drug Administration (FDA) for the maintenance treatment of opioid dependence. Zubsolv should be used as part of a complete treatment plan, including counseling and psychosocial support.

The most effective treatment for opioid dependence is a combination of pharmacological therapy and psychological counseling.[i],[ii] Opioid dependence is a disease, like hypertension, schizophrenia or diabetes, and affects nearly 5 million people across the United States.[iii],[iv],[v] Although it is a treatable condition, even among those diagnosed as opioid dependent, 60% do not receive treatment.[iii] Every year thousands of patients continue to misuse opioids rather than risk the stigma of public exposure by receiving treatment.[vi]

The higher bioavailability of Zubsolv allows for a lower dose of buprenorphine being administered which, in combination with the naloxone component, reduces the amount of available drug and the likelihood of potential misuse and diversion. Zubsolv is the only opioid dependence treatment available today in the highest level of child resistant packaging (F1), and each Zubsolv tablet is supplied in individual unit-dose blister packages, reducing the chance of unintended pediatric exposure

"Orexo is committed to advance the treatment for patients suffering from opioid dependence. Zubsolv was specifically designed to address many of the unmet needs expressed by patients being treated for opioid dependence," said Robert DeLuca, R.Ph., President, Orexo U.S. "In an open-label, crossover study in 28 subjects, we found that ninety-six percent preferred the menthol taste of Zubsolv over the most commonly prescribed formulation of buprenorphine/naloxone."

In addition to the commercial launch of Zubsolv, Orexo issued today the Time and Taste Challenge, inviting patients and prescribers to register to receive demonstration placebo tablets to experience the taste and dissolve time for this new advanced formulation. The placebo tablets are for demonstration purposes only and do not contain active medication. Register for the Time and Taste Challenge at www.zubsolv.com or by calling 1-888-ZUBSOLV.

Orexo is also premiering RISE, a 24/7, real-time, customizable support program informed by patients in recovery. The HIPPA compliant program provides information about opioid dependence and resources to help facilitate a two-way conversation between patients and their chosen mentor network which may also include their doctor and counselor. The program is mobile enabled, allowing for access anytime, anywhere. Visit www.rise-us.com to learn more about the RISE program.

Opioid dependence greatly impacts the U.S. economy, with about $56 billion spent on the disease per year.[vii] In addition, the average healthcare cost per patient with opioid dependence is eight times higher compared to nondependent patients.[viii] There also is a great impact on human life, with almost 17,000 deaths from opioid pain relievers in the U.S. every year.[ix]

Orexo also announced today that it has established a sponsored level 1 American Depositary Receipt (ADR) program in the United States. Orexo's ADR program trades in the US over-the-counter (OTC) market, under the symbol ORXOY, with each ADR comprised of 1 ordinary share. Orexo's ordinary shares are listed on the NASDAQ OMX Stockholm Exchange under the symbol ORX.

For further information contact:
Robert DeLuca, President, Orexo U.S., Inc.
Telephone: 1-973-993-4866

About Opioid Dependence
Opioid dependence is a chronic relapsing disorder like diabetes or high blood pressure, and can develop as a result of either legitimate use or misuse of opioids. Frequent opioid use physically changes the brain, so that the brain starts to think that it needs opioids to function normally. Subsequently, people with opioid dependence experience cravings and symptoms of withdrawal when the effects of opioids begin to wear off.

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 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. Liver function should be monitored before and during treatment.

Children who take Zubsolv sublingual tablet can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Zubsolv is the only opioid dependence treatment that is available in the highest level (F1) child resistant, individual unit-dose packaging, thereby reducing the chance of unintended pediatric exposure. 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.

About Orexo U.S., Inc.
Orexo U.S., 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 an emerging specialty pharma company with commercial operations in the United States and R&D in Sweden developing improved treatments using proprietary drug delivery technology. Orexo's expertise is within the area of reformulation technologies and especially sublingual formulations. The company has a portfolio of revenue-generating U.S. and EU approved products currently marketed under license and a pipeline of several reformulations of approved compounds for areas of unmet medical need. Orexo also has collaboration projects with several international pharmaceutical companies. Orexo AB, with its headquarters in Sweden, is listed on NASDAQ-OMX. The largest shareholders are Novo A/S and HealthCap.

Orexo's proprietary technology relating to Zubsolv is protected by patents and patent applications in the U.S. and other markets worldwide. Projected expiry dates for this IP range from 2019 to 2032.

_______________________________

[i] American Family Physician. "Buprenorphine: Effective Treatment of Opioid Addiction Starts in the Office." May 2006.

[ii] National Institute on Drug Abuse. "Principles of Drug Addiction Treatment: A Research-Based Guide (Third Edition)." December 2012.

[iii] Science & Practice Perspectives. "The Neurobiology of Opioid Dependence: Implications for Treatment." July 2002.

[iv] Cleveland Clinic Journal of Medicine. "Buprenorphine maintenance: A new treatment for opioid dependence." July 2007.

[v] Substance Abuse and Mental Health Services Administration, Results from the 2010 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-41, HHS Publication No. (SMA) 11-4658. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2011.

[vi] Journal of Managed Care Pharmacy. "Empirical view of Opioid Dependence." February 2010.

[vii] Pain Medicine. "Societal Costs of Prescription Opioid Abuse, Dependence, and Misuse in the United States." April 2011.

[viii] Journal of Managed Care Pharmacy. "Direct Costs of Opioid Abuse in an Insured Population in the United States." July/August 2005.

[ix] Centers for Disease Control and Prevention. Prescription Painkiller Overdoses. Accessed July 3, 2013. http://www.cdc.gov/VitalSigns/pdf/2013-07-vitalsigns.pdf.

SOURCE Orexo U.S.



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