>>SOUTH SAN FRANCISCO, Calif., Sept. 9 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc., (Nasdaq: PTIE - News) a biopharmaceutical company, today 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 U.S. 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.
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 WOMACTM Osteoarthritis Index, in physical function measured by a standard SF-12® Health Survey and in patients' self-reported Quality of Analgesia.
"We're delighted to announce these positive Phase III study results with Remoxy," said Remi Barbier, president and chief executive officer. "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."
No drug-related safety issues were noted in this study. As expected, opioid-related adverse events were higher in the Remoxy arm compared to the placebo arm. Adverse events typically associated with chronic opioid use include nausea/vomiting, dizziness, pruritus (itching), and somnolence/sedation. Also as expected, the patient drop-out rate was higher in the Remoxy arm (35%) compared to the placebo arm (24%). Patients in the Remoxy arm dropped mainly due to opioid-related adverse events. Patients in the placebo arm dropped mainly due to lack of efficacy.
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.
About Oxycodone Abuse
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. Long-acting versions of oxycodone are widely used to treat moderate-to-severe chronic pain. However, drug abusers can easily extract oxycodone from Oxycontin® tablets (and all other marketed versions of long-acting oxycodone) in order to induce a quick and powerful euphoric high. Abusers of long-acting oxycodone risk respiratory depression, which can be fatal, and opioid addiction. According to government data, oxycodone abuse resulted in over 20,000 visits to emergency rooms and hundreds of deaths in 2002. Please visit the U.S. Drug Enforcement Administration's website ( www.usdoj.gov/dea ) for more information.
About Remoxy
Remoxy is an investigational drug candidate to treat severe chronic pain. The FDA has not yet evaluated the merits, safety or efficacy of Remoxy. We are developing this drug as an abuse-resistant alternative to marketed forms of long-acting oxycodone. Remoxy has a sticky, high-viscosity mass that resists injection or snorting. Published data show that freezing, crushing or submerging Remoxy in high-proof alcohol for hours at a time releases just a fraction of oxycodone compared to Oxycontin® at time points when abusers presumably expect to get high. We believe these collective properties of Remoxy may deter recreational abuse or accidental patient misuse of long acting oxycodone.<<
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Don't know if FDA would want a head to head trial versus Oxycontin or what. The stock popped into the $7.20 area on the news, and has drifted down to the higher $6s since, not getting much support from an upgrade Monday. I haven't followed this one in a while, but it might take another look here.
Cheers, Tuck |
