Positive Phase 3 Trial Results Announced for Zubsolv

Orexo announced positive results from the ISTART study on Zubsolv (buprenorphine and naloxone) sublingual tablets.

The ISTART study was a PHASE 3 randomized, multicenter, non-inferiority trial that studied the efficacy of Zubsolv vs. Suboxone film (Reckitt Benckiser) during stabilization of patients with opioid dependence (n=758). The co-primary endpoint was treatment retention at Day 15. Secondary endpoints of treatment effects on opioid withdrawal symptoms for Zubsolv vs. Suboxone film were evaluated by the Clinical Opiate Withdrawal Scale (COWS) score and Subjective Opiate Withdrawal Scale (SOWS); opioid cravings were evaluated by the visual analog scale (VAS).

RELATED: Orexo Seeks to Expand Zubsolv Labeling

Zubsolv showed comparable patient retention at Day 15 of treatment vs. Suboxone film (74.9% vs. 74.4%, P=0.866). Also, Zubsolv showed no increase in withdrawal symptoms or opioid cravings vs. Suboxone film at Days 15 and 22.

Zubsolv, a CIII scheduled substance, is approved for maintenance treatment of opioid dependence, as part of a complete treatment plan to include counseling and psychosocial support.

For more information call (855) 982-7658 or visit Zubsolv.com.