Orexo US launches new 8.6/2.1 mg ZUBSOLV® (buprenorphine/naloxone) sublingual tablet CIII: 8.6/2.1mg

MORRISTOWN, N.J., March 6, 2015 /PRNewswire/ -- Orexo US, Inc. (Orexo) announced that following U.S. Food and Drug Administration (FDA) approval, the new 8.6mg/2.1mg dosage strength of ZUBSOLV^® is now available.  This approval is based on the supplemental New Drug Application Orexo submitted to the FDA on December 13, 2013. ZUBSOLV 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. ZUBSOLV sublingual tablets deliver a greater proportion of active ingredient to the bloodstream than other older sublingual buprenorphine/naloxone products, allowing patients to use a lower strength thereby reducing the amount of available drug for potential misuse. The new dosage strength complements the existing strengths of 5.7 mg/1.4 mg and 1.4 mg/0.36 mg tablets and may enable patients to receive their optimal dose in just one tablet.

"Orexo is committed to partnering with healthcare providers and helping patients effectively manage their disease and understands the importance of expanding available treatments for those in need," said Robert DeLuca, R.Ph., President, Orexo. "Treatment plans are typically tailored based on a patient's needs and the approval and launch of the additional ZUBSOLV 8.6/2.1mg tablet improves the ability for physicians and patients to individualize treatment plans, helping patients on their road to recovery."

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

About ZUBSOLV

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.

ZUBSOLV is a maintenance medication for adults with opioid dependence and should be used as part of a complete treatment plan that also includes counseling and behavioral therapy. ZUBSOLV delivers a comparable concentration of active medication to previously approved buprenorphine/naloxone sublingual tablets.¹ In a U.S. study of 758 people with opioid dependence, ZUBSOLV demonstrated comparable retention compared to Suboxone film at Day 15 and in patients who experienced both Suboxone film & ZUBSOLV, more than 70% preferred the advanced formula attributes of ZUBSOLV (menthol flavor, easy to take and mouthfeel).²

Further information on ZUBSOLV can be found at www.zubsolv.com.  

Important Safety Information

Contraindications

• ZUBSOLV sublingual tablet should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported

Warnings and Precautions

• 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. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits
• ZUBSOLV sublingual tablet can cause serious, life-threatening, respiratory depression and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other central nervous system (CNS) depressants (eg, sedatives, tranquilizers, or alcohol). Patients should be warned against self-administration or misuse of these combinations
• Not recommended for initiation of treatment (induction) in patients with moderate hepatic impairment due to the increased risk of precipitated withdrawal. However, buprenorphine/naloxone products may be used with caution for maintenance treatment in patients with moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone. However, patients should be carefully monitored and consideration given to the possibility of naloxone interfering with buprenorphine's efficacy.
• ZUBSOLV sublingual tablet is not recommended in patients with severe hepatic impairment
• Dose reduction of CNS depressants, ZUBSOLV sublingual tablet, or both should be considered in situations of concomitant prescription
• Children who take ZUBSOLV sublingual tablet can have severe, possibly fatal, respiratory depression Intravenous misuse or taking ZUBSOLV sublingual tablet before the effects of full-agonist opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided is likely to cause opioid withdrawal syndrome
• Neonatal withdrawal has been reported following use of buprenorphine by the mother during pregnancy
• ZUBSOLV sublingual tablet is not appropriate as an analgesic. There have been reported deaths of opioid-naive individuals who received a 2-mg sublingual dose of buprenorphine

Use in Specific Populations

• Pregnancy: Based on animal data, buprenorphine may cause fetal harm. Use of ZUBSOLV sublingual tablet in pregnant women or during breastfeeding should only be considered if the potential benefit justifies the potential risk.
• Nursing mothers: Caution should be exercised when buprenorphine-containing products are administered to a nursing woman. The safety of buprenorphine/naloxone in breastfeeding has not been established
• Not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment.

Adverse Reactions

• 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
• This is not a complete list of potential adverse events associated with buprenorphine/naloxone sublingual tablets. Please see full Prescribing Information for a complete list
• To report an adverse event associated with taking ZUBSOLV sublingual tablet, please call 1-888-ZUBSOLV (1-888-982-7658). You are encouraged to report adverse events 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 1-855-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.

Suboxone is a registered trademark of Reckitt Benckiser Healthcare (UK) Ltd.

1. Fischer A, Jonsson M, Hjelmstrom P. Pharmaceutical and pharmacokinetic characterization of a novel sublingual buprenorphine/naloxone tablet formulation in healthy volunteers. Drug Dev Ind Pharm. 2013;1-6. DOI: 10.3109/03639045.2013.846365.
2. Data on file. Orexo US, Inc.

ZUB224B

SOURCE Orexo U.S.

Related Links

http://www.zubsolv.com