Clinical Trial: Safety and Tolerability of Buprenorphine/Naloxone Film Strips

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.

Sponsor: Indivior Inc.

Current Primary Outcome:

  • Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity. [ Time Frame: 12 weeks ]

    Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. Oral mucosa was graded as follows:

    Grade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs

  • Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity [ Time Frame: 12 weeks ]
    Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment.


Original Primary Outcome: Severity and frequency of oral mucosal adverse events [ Time Frame: During active treatment ]

Current Secondary Outcome:

Original Secondary Outcome: Adverse events [ Time Frame: During active treatment ]

Information By: Indivior Inc.

Dates:
Date Received: March 14, 2008
Date Started: February 2008
Date Completion:
Last Updated: November 6, 2012
Last Verified: October 2008