Orexo announced that the Food and Drug Administration (FDA) has approved Zubsolv (buprenorphine/naloxone) sublingual tablets for the induction of buprenorphine maintenance therapy in patients with opioid dependence.
The FDA’s approval of the expanded indication was based on combined data from the Induction, STabilization, Adherence and Retention Trial (ISTART; n=758) and Study OX219-007. The ISTART Trial was a randomized, non-inferiority, multicenter study to assess early treatment efficacy when switching between Zubsolv vs. generic buprenorphine monotherapy for induction and Suboxone Film for opioid maintenance therapy. The primary endpoints were retention in treatment at Day 15 and Day 3. The study demonstrated positive results with >90% of patients treated with Zubsolv remaining on treatment at Day 3 while using a formulation with a 30% lower dose of buprenorphine. The study found no significant differences between the safety profiles of Zubsolv and generic buprenorphine.
Study OX219-007 (n=310) was a prospective, randomized, multicenter, blinded, parallel-group, active-controlled study that compared advanced formulation Zubsolv vs. generic buprenorphine monotherapy for induction of opioid maintenance therapy. The primary endpoint was retention in treatment at Day 3. The study demonstrated 91.8% of patients were retained at Day 3. Clinically and statistically significant improvements were seen in COWS, SOWS, and Craving VAS scores for patients in both randomized groups.
Zubsolv, a CIII controlled substance, was initially approved by the FDA in July 2013. The company plans to launch the new 2.9mg and 11.4mg strengths later this year.
For more information call (855) 982-7658 or visit Zubsolv.com.