Extended-Release Oxymorphone Effective For Osteoarthritis Pain

September 13, 2002

By Peggy Peck

SAN DIEGO, California (Reuters Health) Aug 22 - An investigational

extended-release formulation of oxymorphone demonstrated superior

analgesic efficacy compared with oxycodone CR (OxyContin) and placebo in

a multicenter, randomized, double-blind parallel study of patients with

mild-to-moderate osteoarthritis pain.

The findings were reported here on Wednesday at the 10th World Congress

on Pain.

In an interview with Reuters Health, lead author Dr. Alan K. Matsumoto

said the drug " may be a good therapeutic option for patients with

chronic knee or hip pain, especially since opioids do not have the GI

toxicity associated with NSAIDs. "

But he noted that the study design, just 4 weeks of active treatment,

may have influenced the findings since the analgesic benefit of

oxycodone CR " typically improves over a longer period of time. "

Dr. Matsumoto was on faculty at s Hopkins Medical Institutions,

Baltimore, at the time of the study, but is now in private practice as a

rheumatologist in Wheaton, land.

The study included 467 patients with Kellgren-Lawrence grade II-IV

osteoarthritis of the hip or knee, and index joint pain rated >40mm

(VAS) and incomplete response to NSAIDs. The subjects were randomized to

one of four treatment arms: oxymorphone ER 40 mg; oxymorphone ER 20 mg;

OxyContin 20 mg; or placebo. The medications were all administered every

12 hours. Primary outcome was change in VAS pain after 3 weeks.

At week 3, a statistically significant improvement in pain was seen in

the oxymorphone ER 40-mg and 20-mg groups compared with placebo. This

was sustained at week 4. In contrast, OxyContin did not demonstrate

statistical improvement compared with placebo at weeks 3 or 4.

Fifty-four percent of the patients completed the study. Dr. Matsumoto

said the lower dose oxymorphone ER " appears to be better tolerated than

the high dose. "

Most of the discontinuations in the active treatment groups were for

non-serious opioid side effects and did not vary significantly among

active treatment groups.

The study was funded by Endo Pharmaceuticals Inc. and Penwest

Pharmaceuticals Inc.

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