U.S. FDA Approves Zubsolv® for the Maintenance Treatment of Opioid Dependence

NEW YORK, July 5, 2013 /PRNewswire/ -- Orexo U.S., Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for Zubsolv (buprenorphine and naloxone) sublingual tablets (CIII). Zubsolv is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. Zubsolv is a once-daily, sublingual tablet with higher bioavailability, a fast dissolve time, smaller tablet size and a new menthol flavor.

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Opioid dependence is a disease, like hypertension, schizophrenia or diabetes, and affects nearly 5 million people across the United States.^i,ii,iii Although it is a treatable condition, about 60 percent of opioid dependent patients in the U.S. do not receive treatment.ⁱⁱⁱ Every year thousands of patients continue to misuse opioids rather than risk public exposure by receiving treatment.^iv

"Orexo is committed to helping patients suffering from opioid dependence effectively manage their condition," said Robert DeLuca, R.Ph., President, Orexo U.S., Inc. "The advanced formulation of Zubsolv was developed using our proprietary technology to meet the needs of patients not satisfied with previously approved buprenorphine/naloxone formulations."

Zubsolv sublingual tablets deliver more active ingredient to the bloodstream, allowing patients to use a lower strength thereby reducing the amount of available drug for potential misuse and diversion. In addition, Zubsolv is the only opioid dependence treatment option that is available in the highest level of child resistant unit dose F1 packaging, thereby reducing the chance of unintended pediatric exposure. Furthermore, the naloxone component of Zubsolv reduces the potential for IV misuse and diversion.

The most effective treatment for opioid dependence is the combination of pharmacological therapy and psychological counseling, which is critical in helping to prevent relapse.^v,vi Relapse rates for opioid dependent patients approach 90 percent at six months after detoxification without the use of medication-assisted treatment.^v

"In addiction medicine, the recovery process can be challenging. Products designed to meet patient preferences have the potential to more successfully support their recovery," said Louis E. Baxter, Sr., M.D., FASAM, past president of the American Society of Addiction Medicine. "The approval of Zubsolv provides a new treatment option that offers unique advantages specifically designed to meet the unmet needs expressed by patients. This may have the potential to improve patient adherence, thereby reducing relapse rates and improving successful patient outcomes."

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 is also a great impact on human life, with almost 17,000 deaths from opioid pain relievers in the U.S. every year.^ix

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. Keep Zubsolv sublingual tablet 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 Science & Practice Perspectives. "The Neurobiology of Opioid Dependence: Implications for Treatment." July 2002.
ii Cleveland Clinic Journal of Medicine. "Buprenorphine maintenance: A new treatment for opioid dependence." July 2007.
iii 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.
iv Journal of Managed Care Pharmacy. "Empirical view of Opioid Dependence." February 2010.
v American Family Physician. "Buprenorphine: Effective Treatment of Opioid Addiction Starts in the Office." May 2006.
vi National Institute on Drug Abuse. "Principles of Drug Addiction Treatment: A Research-Based Guide (Third Edition)." December 2012.
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.

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

Media Contact
Ilana Tabak
212-642-7762
Ilana.Tabak@edelman.com

Investor Relations Contact
Nikolaj Sorensen, President and CEO
+ 46-703 50 78 88
Nikolaj.Sorensen@orexo.com

SOURCE Orexo U.S.