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NEW YORK — Orexo U.S. Inc. has received approval from the Food and Drug Administration for Zubsolv sublingual tablets, indicated for the maintenance treatment of opioid dependence.
The company said Friday that the once-daily Zubsolv (buprenorphine and naloxone) pill, which is placed under the tongque, has a fast dissolve time, smaller tablet size and a new menthol flavor.
"Orexo is committed to helping patients suffering from opioid dependence effectively manage their condition," stated Robert DeLuca, president of Orexo U.S. "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."
Orexo noted that Zubsolv sublingual tablets deliver more active ingredient to the bloodstream, enabling patients to use a lower strength and, in turn, reducing the amount of available drug for potential misuse and diversion. In addition, Zubsolv is the only opioid dependence treatment option available in the highest level of child-resistant, unit-dose F1 packaging, lessening the chance of unintended pediatric exposure, the company said. The naloxone component of Zubsolv also is designed to reduce the potential for IV misuse and diversion.
Plans call for Zubsolv to be launched in September, according to Orexo. The medication is is intended to be used as part of a full treatment plan that includes counseling and psychosocial support, the company noted.
Opioid dependence affects nearly 5 million people in the United States, and about 60% of opioid dependent patients don’t receive treatment, Orexo reported. The impact of opioid on the U.S. economy is estimated at about $56 billion spent on the disease per year. Almost 17,000 deaths occur from opioid pain relievers in the United States each year.
"In addiction medicine, the recovery process can be challenging. Products designed to meet patient preferences have the potential to more successfully support their recovery," commented Louis Baxter, M.D., 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."
