FDA Rejects “Safe” Oxy Substitute

FDA Rejects “Safe” Oxy Substitute

By Dirk Hanson 06/28/11

Pfizer goes 1 for 2 with new, harder-to-abuse versions of premier painkiller.

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FDA approved adding niacin for that nasty flush.
Photo via wn

All of the frenzied activity at Pfizer over the development of yet another abuse-proof version of Oxycontin may come to a screaming halt after the Food and Drug Administration (FDA) asked for more information on Remoxy, Pfizer’s version of tamper-proof oxycodone, according to the Wall Street Journal. This is the second rejection, greatly dimming the chances the pill developed by Pfizer and its partners Pain Therapeutics Inc. and Durect Corp. will ever reach the market. The FDA did not say specifically why it was turning down the application, but sources in the pharmaceutical industry say it could be related to manufacturing issues. The oxycodone in Remoxy is encapsulated as a thick liquid, so that it cannot be crushed and snorted, or successfully injected. Other observers speculate that the Obama administration could be about to radically restrict access to oxycodone, or even withdraw it from the market altogether.

Meanwhile, the FDA cleared the way for Oxecta, another proprietary version of abuse-proof oxycodone from Pfizer Inc. and Acura Pharmaceuticals Inc., which relies on the addition of a hefty dose of niacin to cause irritation and flushed, painful skin if patients take too much. At this stage, it appears that the FDA favors adding adulterants to oxycodone over turning it into goo.

Last summer, Purdue Pharma, makers of Oxycontin, reformulated their painkiller to make it harder to crush, using an approach virtually identical to the one the FDA rejected—turning the powder into a partial jelly. Addicts are ingenious and hard to discourage, and FDA officials may also be worrying about overdoses caused by addicts attempting to snort or shoot the newer versions by combining them with harmful adulterants and solvents, and accidentally overdosing in the attempt. All of this makes the FDA rejection seem even more arbitrary, unless the end of the oxycodone era is about to be announced.