Abstract
An extended-release (ER) hydrocodone tablet formulated using OraGuard™ technology was developed to provide sustained pain relief while protecting against rapid release of hydrocodone when tablets are comminuted or taken with alcohol. Aberrant drug-related behaviors and addiction were evaluated in a 12-month, phase 3, open-label study. Eligible patients had either previously completed a 12-week, randomized, placebo-controlled study of ER hydrocodone or were newly enrolled with chronic (≥3 months) noncancer pain; excluded were those taking oxycodone 135 mg/day (or equivalent) for 14 days or with recent history/current substance/alcohol abuse.
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