Zubsolv® - against opioid dependence

Zubsolv® is a product for the treatment of opioid dependence. In July 2013, Zubsolv was approved for the maintenance treatment of opioid dependence by the U.S. Food and Drug Administration, FDA, and in August 2015 the product received approval for induction treatment.

Product information for press and investors

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.

More information about Zubsolv can be found at www.zubsolv.com
(for US citizens only)