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news.Biopharmaceutical company Pain Therapeutics has completed the enrollment and initiation of dosing in its phase III study with counter abuse pain treatment Remoxy.
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Remoxy is a novel, abuse-resistant form of long-acting oxycodone, which is the active ingredient in popular but prone to abuse pain medication Oxycontin.
The double-blind, randomized, multi-center phase III clinical study is designed to evaluate the safety and efficacy of twice-a-day Remoxy against placebo over a one-month treatment period. Over 200 US patients with moderate-to-severe pain due to advanced osteoarthritis were enrolled.
Pain Therapeutics expects to announce study results in the third quarter of 2005, which is ahead of the company’s previously announced clinical guidance. The company also expects to initiate a second phase III study with Remoxy in the fourth quarter of 2005.
“Pain is a complex and chronic condition in these patients,” said Remi Barbier, Pain Therapeutics’ president and CEO. “Oxycodone can help, but its potential for abuse and illicit diversion remains of great concern to health officials and law enforcement groups.
“Remoxy’s unique formulation makes it exceedingly difficult and frustrating for drug abusers to extract the oxycodone in Remoxy for purposes of getting high. We believe this feature strongly differentiates Remoxy from currently marketed forms of long-acting oxycodone.”