Alpharma: phase 2 results show anti-abuse properties of extended-release opioid

By Lisa Kerner

Charlotte, N.C., Sept. 29 - Alpharma Inc. said the phase 2 multi-dose, multi-center clinical efficacy and pharmacokinetic trial for its abuse-deterrent, extended-release opioid met its goal by not impacting the safety or efficacy of the Kadian.

The proprietary technology includes naltrexone in a single-dose tablet, which abates any euphoric effect if the tablet is crushed, chewed or dissolved.

Pain scores were similar in patients using the abuse-deterrent extended-release opioid to those receiving Kadian.

Efficacy was assessed using the Brief Pain Inventory scale and the Western Ontario and MacMaster Universities Osteoarthritis Index in 69 patients completing the study.

The company said it will seek Food and Drug Administration approval in 2008 and began the necessary pivotal phase 3 clinical program. Patient enrollment is slated for the fourth-quarter 2006.

Alpharma is a global specialty pharmaceutical company based in Fort Lee, N.J.

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