Pain Therapeutics, Inc., a biopharmaceutical company, has reported positive Phase III results with Remoxy, an abuse-resistant form of long-acting oxycodone.
In this study, the safety and efficacy of Remoxy was compared against placebo in osteoarthritic patients with moderate-to-severe chronic pain. This Phase III study design was randomized, double-blinded and enrolled 209 patients in over 20 US clinical sites. Patients were treated with Remoxy 20 mg or matching placebo twice daily over a 4-week study period. Patient demographics and baseline pain scores were similar in both arms, according to a company release.
The primary objective of this study was to evaluate pain relief. Results demonstrated a statistically significant difference (p<0.05) between Remoxy and placebo in the study's primary endpoint: percent decrease in pain scores from baseline to final study visit, measured with a standard Likert Pain Scale.
The secondary objective of this study was to evaluate patients' quality of life. Results demonstrated statistically significant differences (p<0.05) between Remoxy and placebo in each component of the Womac Osteoarthritis Index, in physical function measured by a standard SF-12 Health Survey and in patients' self-reported Quality of Analgesia.
Remi Barbier, president and chief executive officer said, "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."
Pain Therapeutics' next step with Remoxy is to conduct a large, pivotal Phase III registration study that can support a New Drug Application under an FDA filing strategy known as 505(b)(2). The Company expects to initiate this study by year-end 2005, the release stated.
Oxycodone is a strong opioid painkiller and is the active drug ingredient in Remoxy. Oxycodone is also the active drug ingredient in Oxycontin, a brand name drug with sales of nearly $2 billion in 2004.
Remoxy is an investigational drug candidate to treat severe chronic pain. The FDA has not yet evaluated the merits, safety or efficacy of Remoxy.