New Strength of Anti-Opioid Launched in United States

Orexo has recently announced that the 8.6-mg/2.1-mg dosage strength of its partial opioid agonist, buprenorphine and naloxone (Zubsolv), is now available in the United States.

This announcement follows the FDA’s approval of the supplemental New Drug Application for the new strength, which was submitted to the agency in December 2013.

“Orexo is committed to partnering with health care providers and helping patients effectively manage their disease and understands the importance of expanding available treatments for those in need,” said Orexo President Robert DeLuca, RPh, in a press release. “Treatment plans are typically tailored based on a patient's needs, and the approval and launch of the additional Zubsolv 8.6/2.1-mg tablet improves the ability for physicians and patients to individualize treatment plans, helping patients on their road to recovery.”

Zubsolv, a sublingual tablet indicated for the maintenance treatment of opioid dependence, is also available in 5.7-mg/1.4-mg and 1.4-mg/0.36-mg strengths.