An FDA advisory committee determined that Remoxy is less susceptible to abuse than the notorious OxyContin, suggesting the pill will win FDA approval,Bloomberg News reports, although the committee did not take a formal vote.
Most panel members, though, spoke favorably of Remoxy's tamper-resistant characteristics. The pill is a taffy-like capsule containing oxycodone, the same narcotic found in Purdue Pharma's OxyContin, and is designed to be taken twice a day for chronic pain.
King and its partner, Pain Therapeutics, are among a half-dozen drugmakers racing to introduce the first drugs for chronic pain that can't be crushed, snorted or injected for a quick high (see photo). While some researchers say all narcotic painkillers will be reformulated, King estimates even a 5 percent share of the market may bring $700 million in sales.
"As a drug-abuse researcher, there's pretty good evidence that this would be less likely to be abused,'' panel member Harriet de Wit, a University of Chicago psychiatry professor, said at the meeting in Gaithersburg, Maryland. "At the very least, it would be more difficult and burdensome to abuse.''
The FDA is scheduled to act by December 10 under a six-month priority review granted to drugs the agency considers significant improvements over available therapies.
Remoxy would be Pain Therapeutics' first drug, and it would be sold by King if it's approved. Sales may be $300 million to $1.6 billion in 2010 depending on competition from OxyContin and other products, according to Corey Davis, an analyst at Natixis Bleichroeder in New York.
Yet almost half of the panelists said evidence was insufficient to show that Remoxy was significantly better than OxyContin. "When I hear these comments that it's tamper-resistant, I worry about it because that's exactly what Purdue did at the beginning of OxyContin,'' said panel member Sidney Wolfe, director of the Health Research Group at Public Citizen. "They said don't worry.''
About 1.8 percent of people ages 12 and older have taken OxyContin for non-medical reasons, according to a 2007 National Survey on Drug Use and Health that was presented at the panel's meeting.
Panel members also expressed doubts about including data concerning Remoxy's abuse-resistance in the drug's prescribing info if it is approved. The FDA has said it is reluctant to allow such claims for painkillers because abusers of OxyContin may have gotten ideas from labeling that warned crushing the time-release drug would deliver its medicine all at once.
Closely held Purdue, of Stamford, Connecticut, agreed last year to pay $634.5 million to settle claims that promotions from 1996 to 2001 misled doctors about the risks of OxyContin.