Orexo announced the FDA approval for Zubsolv (buprenorphine and naloxone) sublingual tablets indicated for the maintenance treatment of opioid dependence as part of a complete treatment plan, which includes counseling and psychosocial support.
Zubsolv is a schedule CIII narcotic that combines buprenorphine, an opioid (partial agonist-antagonist), and naloxone, an opioid antagonist. Naloxone reduces the potential for IV misuse and diversion.
Zubsolv sublingual tablets have increased bioavailability of the active ingredient, which allows patients to use a lower strength. This reduces the amount for potential misuse and diversion. Also, Zubsolv is available in the highest level of child resistant unit dose F1 packaging, which reduces the chance of unintended pediatric exposure.
Zubsolv sublingual tablets will be available in 1.4mg/0.36mg and 5.7mg/1.4mg strengths as a menthol flavor. Orexo anticipates its launch in September 2013.
For more information call (888) ZUBSOLV or visit Orexo.com.