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news.Pain Therapeutics has reported positive phase III results with Remoxy, an abuse-resistant form of long-acting oxycodone for the treatment of severe chronic pain.
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In the study, the safety and efficacy of Remoxy was compared to placebo in osteoarthritic patients with moderate-to-severe chronic pain. This phase III study enrolled 209 patients in over 20 US clinical sites. Patients were treated with Remoxy 20mg or matching placebo twice daily over a four-week study period.
Results demonstrated a statistically significant difference between Remoxy and placebo in pain decrease, and physical function.
“We’re delighted to announce these positive phase III study results with Remoxy,” said Remi Barbier, president and CEO of Pain Therapeutics. “These positive data allow us to forge ahead with Remoxy’s clinical development. We also believe these data open doors to various commercial options for Remoxy, such as launching this drug by ourselves or with a pharmaceutical firm that shares our vision of the market potential for this drug.”
As expected, opioid-related adverse events were higher in the Remoxy arm compared to the placebo arm of the trial. Adverse events typically associated with chronic opioid use include nausea/vomiting, dizziness, pruritus (itching), and somnolence/sedation.