MORRISTOWN, N.J., Oct. 6, 2016
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.
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
Warnings and Precautions
Use in Specific Populations
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.
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.
Robert A. DeLuca, President
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SOURCE OrexoPR Newswire
Last updated on: 06/10/2016
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