Safety and Tolerability of Buprenorphine/Naloxone Film Strips

Opioid-Related Disorders Clinical Trial

Official title: A Phase 2 Multi-Center Open-label Study to Assess the Safety and Tolerability of a Buprenorphine/Naloxone Film Strip Administered by the Sublingual and Buccal Routes

Status Completed

Clinical Trial Summary

This study will evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a stable regimen of buprenorphine/naloxone.

Clinical Trial Description

Buprenorphine and naloxone soluble film was developed as an alternative dosage form to Suboxone (buprenorphine and naloxone) sublingual tablets and was evaluated for both sublingual and buccal administration. The soluble film dosage is expected to provide the following enhancements and potential advantages over the current Suboxone (buprenorphine and naloxone) product:

• mitigation against unintentional pediatric exposure by providing child-resistant packaging in unit dose format.

• improvement in subject convenience and compliance by ensuring rapid disintegration.

• protection against diversion by providing a dosage form that is very difficult for the subject to remove from the sublingual or buccal mucosa after administration. This provides assurance to the caregiver that the dose has actually been taken appropriately in a supervised setting.

• provision of a unit dose product format for hospital and institutional use.

• decreased product damage during shipping as compared to Suboxone tablets. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid-Related Disorders

• NCT number: NCT00640835
• Study type: Interventional
• Source: Indivior Inc.
• Status: Completed
• Phase: Phase 2
• Start date: February 2008
• Completion date: October 2008