Any chance you'd answer my question? Thanks.
Anyhow, decent if not spectacular news for Pain Therapeutics (PTIE):
>>SOUTH SAN FRANCISCO, Calif., Dec. 6 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. (Nasdaq: PTIE - News), a biopharmaceutical company, today announced clinical results that demonstrate Remoxy is significantly less abusable than Oxycontin.
Remoxy is a proprietary, abuse-resistant form of long-acting oxycodone, a powerful narcotic painkiller. Oxycodone is also the active ingredient in Oxycontin, a brand name drug with sales of nearly $2 billion. In recent years, the U.S. Drug Enforcement Administration and the national media have linked oxycodone with widespread patterns of abuse, addiction, diversion and overdose.
Pain Therapeutics conducted a head-to-head comparison of the abusability of Remoxy versus Oxycontin. In this clinical study, 10 human volunteers consumed a crushed dose of Remoxy or Oxycontin with a glass of water. The study was repeated in the same subjects two days later, only this time they consumed a crushed dose of Remoxy or Oxycontin with high-proof alcohol. During each study, levels of oxycodone (the active ingredient in both drugs) were measured from the volunteers' blood samples. In both cases, oxycodone levels were significantly lower in the Remoxy group than in the Oxycontin group within 120 minutes of ingestion (p<0.05), when drug abusers presumably expect to get high.
The data from this study provides fresh evidence that Remoxy has the potential to deter oxycodone abuse since it is absorbed much more slowly than Oxycontin when crushed and consumed. Pain Therapeutics plans to initiate a Phase III study with Remoxy later this month.
"Oxycodone abuse remains a critical public heath issue in parts of the United States," said Remi Barbier, Pain Therapeutics' president and chief executive officer. "Remoxy is our response to this problem. This drug candidate has a novel formulation that prevents oral abuse, injection or snorting. These properties, coupled with a potential $2 billion market opportunity, define our strategy to expedite Remoxy's clinical development in a manner that is safe, thoughtful and meaningful."
Pulverized Study Details
This clinical study assessed the integrity of the long-acting mechanisms of Remoxy vs. Oxycontin following a common method of oxycodone abuse: pulverizing a dose of the drug and consuming it with water or with high-proof alcohol. The goal of this study was to quantitate the absorption of long-acting oxycodone in human volunteers after physical disruption of an oral dose of Remoxy or Oxycontin.
Following approval of this protocol by an Ethics Committee, and after signing an informed consent form, 10 healthy volunteers consumed a pulverized 10 mg dose of Remoxy or Oxycontin with a glass of water. Two days later the same human volunteers consumed a pulverized 10 mg dose of Remoxy or Oxycontin with one ounce of high-proof alcohol. Blood samples were taken 48 hours post-dosing. Oxycodone plasma concentrations were assessed over time (AUC-Area Under the Curve) from these blood samples.
Study Results
Mean plasma oxycodone was significantly lower in the Remoxy group compared to the Oxycontin group.
AUC differences were statistically significant (p<0.05) in the time points when abusers expect to get high.
Mean AUC (hr.ng/ml)
Crushed Remoxy Crushed Oxycontin
Water Alcohol Water Alcohol
AUC 0-60 mins 3.2 2.4 12.6 11.4
AUC 0-120 mins 8.0 8.4 29.5 26.3
Study Discussion
These differences in AUCs demonstrate that significantly less oxycodone is released from Remoxy as compared to Oxycontin. Also, the Oxycontin-water group reported many adverse events, including dizziness, relaxation, euphoria, fatigue and, in one person, a large drop in blood pressure. In comparison, there was a single adverse event (lethargy) in the Remoxy-water group.
In an anti-abuse study previously announced in June 2004, human volunteers consumed Remoxy and Oxycontin formulations that were only partially destroyed by chewing or stirring in high-proof alcohol. In that study, plasma concentrations of oxycodone were lower in the Remoxy group than in the Oxycontin group and this difference was statistically significant (p<0.05) in the first hour and at other time points.
When used as directed, Remoxy provides twice daily dosing. However, test results indicate that crushing Remoxy does not trigger a significant release of its oxycodone content compared to Oxycontin. Likewise, attempts to chew or to stir Remoxy in high-proof alcohol releases just a fraction of its oxycodone content compared to Oxycontin. In addition, Remoxy's sticky, high-viscosity capsule formulation makes it nearly impossible for drug abusers to snort or inject the drug. These properties make Remoxy an unattractive choice for drug abusers who are looking to achieve a quick or powerful euphoric high. Remoxy's unique formulation also prevents patients from accidentally overdosing or intentionally misusing long-acting oxycodone.
About Oxycodone Abuse
Oxycodone abuse and diversion is of great concern to U.S. health officials and law enforcement groups. Abusers can easily extract the full dose of oxycodone from currently marketed long-acting preparations, resulting in an immediate and large spike in oxycodone blood levels. This provides abusers with a fast and powerful morphine-like high. Recreational use of oxycodone can also lead to respiratory depression, death or opiate addiction. In 2002, oxycodone abuse resulted in over 20,000 visits to Emergency Rooms and hundreds of deaths in the U.S. Please visit the U.S. Drug Enforcement Administration's website for more information: usdoj.gov .
About Remoxy
Remoxy is an oral, long-acting oxycodone capsule that incorporates several abuse-deterrent properties and offers the convenience of twice-a-day dosing. Tests indicate that crushing or physically manipulating Remoxy does not defeat its long-acting mechanism. Remoxy can also resist extraction by acids or alcohol for hours at a time by entrapping a majority of its oxycodone inside its proprietary formulation.
About Pain Therapeutics, Inc.
We are a biopharmaceutical company that develops novel drugs. Our drugs target severe chronic pain, such as pain associated with osteoarthritis, low-back pain or irritable bowel syndrome. We have three unique drug candidates in clinical development: OxytrexTM, Remoxy and PTI-901. Our two most advanced drugs, Oxytrex and PTI-901, are in Phase III clinical trials. We believe the target market for our three drug candidates exceeds $3 billion per year. We currently retain commercial rights to our drug candidates.
For more information, please see Pain Therapeutics' website, www.paintrials.com. <<
snip
Cheers, Tuck |
