Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain

A Double-Blind, Double-Dummy, Placebo- and Active Controlled Evaluation of the Efficacy, Safety and Tolerability of Buprenorphine HCl Buccal Film in the Treatment of Pain Associated With Third Molar Extraction

The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.

Inclusion Criteria:

• extraction of 2 or more third molars, at least 1 of which must be fully or partially impacted in mandibular bone
• males or non-pregnant females, aged 18 to 45 years
• good general health and capable of providing informed consent

Exclusion Criteria:

• history of substance abuse or dependence
• positive urine toxicology screen or alcohol breath test
• history of hypersensitivity to or allergy to any study drug
• donation of blood within prior 30 days
• use of analgesics, caffeine, sedatives, antidepressants, anticoagulant or antiplatelet agents within 24 hours