April 26, 2011
Participants in a clinical trial didn't like Pain Therapeutics (Nasdaq: PTIE ) and Pfizer's (NYSE: PFE ) painkiller Remoxy as much as Purdue Pharma's OxyContin. But the duo didn't mind. In fact, they were trumpeting the results of the study.
You see, the participants in the study were drug abusers, and Remoxy is an abuse-deterrent formulation of the same active ingredient as OxyContin. Not liking to abuse the drug is kind of the point.
Remoxy uses DURECT's (Nasdaq: DRRX ) technology to slowly release the pain drug that's encapsulated in a gel that makes it hard to get the active ingredient out all at once. Despite their best efforts, the study participants couldn't chew on the drug for more than 90 seconds because it tastes so bad. The drug abusers preferred the extended release OxyContin because they could be easily crushed to release all of the active compound at once.
Last week, the Food and Drug Administration said that all drugmakers -- from Pfizer and Johnson & Johnson (NYSE: JNJ ) down to generic drugmakers Teva Pharmaceuticals (Nasdaq: TEVA ) and Mylan (Nasdaq: MYL ) -- that sell Long-Acting and Extended-Release Opioids had to establish a single comprehensive plan to instruct doctors about how to make sure the patients that need the drugs get them but that they stay out of the hands of drug abusers.
Remoxy was originally up for review by the FDA in 2008 when the agency said it wanted more information about the abuse-deterrent part of the drug. We'll know soon enough whether Remoxy can get past the agency when the FDA makes a new decision on or around June 23. Considering the agency's new stance on prescription drug abuse and the new data that Pain and Pfizer have in hand, Remoxy should have an easier time getting liked by the FDA.
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