AAPM: Remoxy Efficacious for Pain, Prevents Dose Dumping

New sustained-release formulation of oxycodone effectively treats pain, may prevent misuse
By Pat F. Bass, M.D.
HealthDay Reporter

WEDNESDAY, Sept. 10 (HealthDay News) -- Remoxy effectively treats pain and also prevents common 'dose dumping' techniques used by abusers to obtain euphoria, according to two abstracts presented at the American Academy of Pain Management held Sept. 8 to 11 in Nashville, Tenn.

In the first presentation, Annelies de Kater, Ph.D., of Pain Therapeutics, Inc. in San Mateo, Calif., and colleagues performed a single-center, randomized, four-way crossover study to determine the effect of alcohol on the rate and extent of absorption of oxycodone from Remoxy. Participants ingested a single Remoxy 40-mg capsule with 240 mL of either water alone, or 4, 20 or 40 percent ethanol. No significant differences in maximal concentration of oxycodone or concentration over time were noted.

In the second study, Tim Merrigan, M.D., also of Pain Therapeutics, Inc. and colleagues performed a phase III study to test the safety and efficacy of Remoxy. Patients (n=412) with moderate-to-severe osteoarthritis of the hip or knee were randomized to twice daily Remoxy or placebo over 12 weeks. Patients self-titrated (between 10-80 mg total daily dose) their study medication during weeks 1 to 4, and the dose became fixed during weeks 5 to 12. Pain intensity scores significantly declined during the treatment period and Global Assessment and Quality of Analgesia scores significantly improved, the researchers report.

"Remoxy is highly resistant to dissolution in alcohol, and consuming Remoxy with up to 40 percent ethanol did not defeat its controlled-release formulation," de Kater and colleagues write. "These data suggest that Remoxy represents a safer alternative to current controlled-release oxycodone." Merrigan points out that "this is the first large, well-controlled clinical study demonstrating analgesic efficacy of an abuse-resistant, controlled-release formulation of oxycodone. Surprisingly, we believe this is also the first study to ever demonstrate the analgesic efficacy of any twice-daily formulation of oxycodone over 12 weeks in patients with chronic pain."

Both studies were supported by Pain Therapeutics, Inc. and King Pharmaceuticals, Inc.

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