Orexo U.S., Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for Zubsolv (buprenorphine and naloxone) sublingual tablets (CIII). Zubsolv is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. Zubsolv is a once-daily, sublingual tablet with higher bioavailability, a fast dissolve time, smaller tablet size and a new menthol flavor.
Opioid dependence is a disease, like hypertension, schizophrenia or diabetes, and affects nearly 5 million people across the United States.i,ii,iii Although it is a treatable condition, about 60 percent of opioid dependent patients in the U.S. do not receive treatment.iii Every year thousands of patients continue to misuse opioids rather than risk public exposure by receiving treatment.iv
“Orexo is committed to helping patients suffering from opioid dependence effectively manage their condition,” said Robert DeLuca, R.Ph., President, Orexo U.S., Inc. “The advanced formulation of Zubsolv was developed using our proprietary technology to meet the needs of patients not satisfied with previously approved buprenorphine/naloxone formulations.”
Zubsolv sublingual tablets deliver more active ingredient to the bloodstream, allowing patients to use a lower strength thereby reducing the amount of available drug for potential misuse and diversion. In addition, Zubsolv is the only opioid dependence treatment option that is available in the highest level of child resistant unit dose F1 packaging, thereby reducing the chance of unintended pediatric exposure. Furthermore, the naloxone component of Zubsolv reduces the potential for IV misuse and diversion.
The most effective treatment for opioid dependence is the combination of pharmacological therapy and psychological counseling, which is critical in helping to prevent relapse.v, vi Relapse rates for opioid dependent patients approach 90 percent at six months after detoxification without the use of medication-assisted treatment.v
“In addiction medicine, the recovery process can be challenging. Products designed to meet patient preferences have the potential to more successfully support their recovery,” said Louis E. Baxter, Sr., M.D., FASAM, past president of the American Society of Addiction Medicine. “The approval of Zubsolv provides a new treatment option that offers unique advantages specifically designed to meet the unmet needs expressed by patients. This may have the potential to improve patient adherence, thereby reducing relapse rates and improving successful patient outcomes.”
Opioid dependence greatly impacts the U.S. economy, with about $56 billion spent on the disease per year.vii In addition, the average healthcare cost per patient with opioid dependence is eight times higher compared to nondependent patients.viii There is also a great impact on human life, with almost 17,000 deaths from opioid pain relievers in the U.S. every year.ix
