The San Francisco-based company said Wednesday its experimental gel capsule resists the easy tampering that turns the approved pill from a legally prescribed painkiller for long-suffering patients into a potent and sometimes fatal high for drug abusers.
OxyContin was hailed as a breakthrough in the treatment of severe chronic pain when it was introduced in 1996. But the drug has become a problem in recent years after users discovered that crushing the time-release tablets and snorting or injecting the powder yields an immediate, heroin-like high.
Pain Therapeutics chief executive Remi Barbier said the company's Remoxy is a sticky gel cap, which makes it hard to ground into powder and that the active ingredient — oxycodone — is difficult to extract when submerged in alcohol and water, two popular ways to refine OxyContin for abuse.
"We have caged it in a number of molecules and chemicals that makes it very difficult, if not impossible, to separate the formula," Barbier said.
Hundreds of overdose deaths have been attributed to OxyContin abuse and have overshadowed the drug's legitimate use by cancer patients and others who suffer from chronic pain.
Drug counselors, lawmakers and others have been advocating for a harder-to-abuse version of OxyContin, which remains popular despite its negative publicity, highlighted recently by radio commentator Rush Limbaugh's admission he has misused OxyContin.
Last year, about 7 million OxyContin prescriptions were written for about $1.27 billion in sales, its manufacturer Purdue Pharma of Stamford, Conn., has said.
The gel technology used to create Remoxy was developed by Cupertino-based Durect Corp., which will share with Pain Therapeutics in any future profits the drug may garner.
"Given a choice between prescribing abuse-resistant Remoxy or easily abusable controlled-release oxycodone, we believe physicians will choose the less abusable alternative," said Dr. Nadav Friedmann, Pain Therapeutics' chief operating and medical officer.
However, Remoxy has yet to be tested in people and the company is at least two years from applying for Food and Drug Administration approval.
Pain Therapeutics has asked the FDA for permission to begin initial human experiments by March and a larger study by the end of 2004, the company said Wednesday. The company said it hopes to present Remoxy to the FDA for marketing approval by the middle of 2005.
"That's a very aggressive timeline," said Ken Trbovitch, an analyst with C.E. Unterberg, Towbin. "Could they do it? Sure. But it's highly unlikely."
The privately held Purdue Pharma's Web site said the company "has committed hundreds of millions of dollars" attempting to create its own tamper-resistant drug. Company spokesman James Heins said Purdue doesn't expect to file for approval of that drug, which is currently being tested in human experiments, for another four to five years.
"This is difficult science," he said.
Heins wouldn't comment on Pain Therapeutics' project, but said the FDA is expected to give higher scrutiny to any new oxycodone-based painkillers because of the abuse issue. Further, any new technology can't completely eradicate misuse of painkillers, he said.
"Even the most abuse-resistant medication is not going to be abuse proof," Heins said.