Extended-Release Drug for Chronic Low Back Pain Meets Endpoint
Purdue Pharma announced results from a Phase 3 study of an extended-release formulation of hydrocodone bitartrate compared with placebo in patients with chronic low back pain. The study drug met its primary efficacy endpoint of the reduction of mean pain intensity over a 24-hour period compared to placebo (P=0.0016).
The double-blind, randomized, multi-center, placebo-controlled Phase 3 study enrolled 588 opioid-naive and opioid-experienced patients with moderate to severe chronic low back pain who were evaluated over a 12-week double-blind span. Forty-eight percent of patients receiving hydrocodone bitartrate reported a 50% improvement in pain intensity. The majority of hydrocodone bitartrate patients receiving the dose reported at least a 30% improvement in pain intensity. The dose of hydrocodone bitartrate extended-release was increased once every 3–5 days as needed until a stable once-daily dose was determined (20–120mg).
The company reports that it has completed studies of laboratory manipulation and extraction, pharmacokinetics, and clinical abuse potential. This single-entity opioid formulation utilized abuse-deterrent properties intended to make the tablets more difficult to manipulate for the purpose of misuse and abuse by various routes of administration.
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