U.S. FDA Approves Orexo's Low Dose ZUBSOLV® Buprenorphine and Naloxone Sublingual Tablets (CIII)

MORRISTOWN, N.J., Oct. 6, 2016 /PRNewswire/ -- Orexo US announced today that the U.S. Food and Drug Administration (FDA) has approved ZUBSOLV^® (buprenorphine/naloxone CIII sublingual tablet) 0.7mg/0.18mg for the treatment of patients with opioid dependence. This approval extends ZUBSOLV's market lead in dosages offered to physicians and patients. This broad range of dosages enables single tablet dosing flexibility by offering six different tablet doses (11.4mg/2.9mg, 8.6mg/2.1mg, 5.7mg/1.4mg, 2.9mg/0.71mg, 1.4mg/0.36mg & 0.7mg/0.18mg).  Upon launch of the 0.7mg/0.18mg tablet in early 2017, ZUBSOLV will provide physicians with the broadest dosing armamentarium, including the lowest available single dose.   ZUBSOLV was originally approved by the FDA on July 3, 2013 in two dosages of 5.7mg/1.4mg and 1.4mg/0.36mg sublingual tablet strengths.  Since then, Orexo has received FDA approval of 4 additional dosage strengths advancing the offering available to the market.  This advancement in product development is based directly on physician feedback on the importance of improving dosing flexibility and allowing for tailored treatment that meets individual patient needs.

"The FDA approval of the 0.7mg/0.18mg dose constitutes yet another important milestone for the opioid dependent community and Orexo.  We are proud that in just three years we have been able to listen to physicians' concerns regarding the importance of providing greater dosing flexibility for patients and have succeeded in our product development strategy to bring tangible treatment opportunities to the community we serve. ZUBSOLV extends its widest range of dosage strengths offered which further enables single tablet once daily dosing including the lowest dosage strength available," said Robert A. DeLuca, President of Orexo US.

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 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 US 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-naïve 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

Orexo is a specialty pharmaceutical company with global headquarters and R&D based in Uppsala, Sweden and a commercial subsidiary based in Morristown, New Jersey. Orexo's share are listed on Nasdaq Stockholm Exchange Mid Cap (STO: ORX) and is available as ADRs on OTCQX (ORXOY) in the US.

For more information about Orexo, please visit www.orexo.com 

ZUBSOLV is a licensed trademark of Orexo US, Inc.
Suboxone is a registered trademark of Indivior UK Limited

1.     Fischer A, Jönsson M, Hjelmström 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.

ZUB527

CONTACT:
Robert A. DeLuca, President
973-936-6990
[email protected]

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SOURCE Orexo

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