FDA Approves New Anti-Opioid Addiction Drug Strength

The FDA approved a new 2.9-mg/0.71-mg dosage strength of Orexo’s sublingual buprenorphine/naloxone (Zubsolv), a partial opioid agonist indicated for the maintenance treatment of opioid dependence.

The new dosage strength will allow patients to receive their optimal dose in 1 tablet with higher bioavailability and a fast dissolve time. These features can potentially increase treatment compliance, reduce relapse rates, and improve patient outcomes, according to a manufacturer press release.

“The new tablet strength complements the existing dosage range and enables more patients to get the right dosage in only 1 tablet and thus reduces the need to combine different dosage strengths,” said Orexo president and CEO Nikolaj Sørensen in a press release. “The approval of 2.9 mg/0.71 mg brings Orexo one step closer to having the broadest dosage range within opioid addiction treatment.”

An 8.6-mg/2.1-mg dosage strength of Zubsolv was launched in the United States in March. The drug is also currently available in 5.7-mg/1.4-mg and 1.4-mg/0.36-mg strengths.

Orexo plans to launch the new 2.9 mg/0.71 mg Zubsolv during second half of 2015.