FDA APPROVES TWO HIGHER DOSAGE STRENGTHS OF ZUBSOLV.
Orexo AB has received approval from the U.S. Food and Drug Administration (FDA) of two higher dosage strengths of ZUBSOLV (buprenorphine/naloxone CIII sublingual tablet) for maintenance treatment of opioid dependence. The new dosage strengths are 8.6 mg/2.1 mg and 11.4 mg/2.9 mg buprenorphine/naloxone CIII sublingual tablets. The 8.6 mg/2.1 mg dosage strength is expected to be launched early 2015 and the 11.4 mg/2.9 mg strength later in 2015.
The new dosage strengths complement the existing strengths of 5.7 mg/1.4 mg and 1.4 mg/0.36 mg tablets and enable patients to receive their optimal dose in one tablet. The new strengths are made with the advanced, proprietary sublingual tablet formulation in ZUBSOLV providing higher bioavailability, a fast dissolve time, small tablet size, and menthol flavor.
The advanced formulation provided by ZUBSOLV meets the needs expressed by patients, such as improved taste and fast dissolve time. Meeting patient needs may have the potential to improve patient adherence, thus reducing relapse rates and improving successful patient outcomes. ZUBSOLV is the only opioid dependence treatment option available in the highest level of child resistant, unit dose, F1 packaging, designed to reduce the chance of unintended pediatric exposure.
About Orexo AB
Orexo is a specialty pharma company with commercial operations in the United States and R&D in Sweden developing improved treatments using proprietary drug delivery. The company is commercializing its proprietary product, ZUBSOLV sublingual tablets, for maintenance treatment of opioid dependence, in the United States. The ZUBSOLV sublingual tablet is a novel formulation of buprenorphine and naloxone using Orexo's extensive knowledge in sublingual technologies. For information about Orexo, visit www.orexo.com.
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).
For more information, visit www.zubsolv.com or call +46 (0)703-50 78 8.