FDA turns down Pfizer drug Remoxy
After recently approving a form of the painkiller oxycodone designed to deter abuse, the Food and Drug Administration appears to be giving a colder shoulder to another form, also designed to prevent abuse.
Both are made by Pfizer. The company offered up a few details of its back-and-forth with the FDA in a news release issued Friday.
The drug company didn’t say precisely what issues the FDA had with Remoxy, an extended-release form of oxycodone, but they’ve existed for a while, as noted by MedPage Today. The agency turned the drug down in 2008 too. Pfizer said it was working to evaluate the agency’s issues with the drug.
But on Monday, Pfizer got the agency’s blessing for Oxecta, an immediate-release oxycodone drug designed to discourage snorting or injection.
Extended-release drugs tend to be prescribed for chronic pain and contain more of the active ingredient than immediate release drugs—an attractive element to someone seeking to abuse the drug.
The Motley Fool ruminated on Remoxy’s fate earlier this week:
“In theory, the approval for Oxecta should bode well for Remoxy, but this is the FDA, and you never know what you’re going to get. Sometimes it seems like the agency gets its kicks from abusing drugmakers.”
In this case, the drug-maker Pfizer had this to say about the drug’s future:
“Pfizer is working to understand and address the issues in the FDA Complete Response Letter. Pain is an important strategic disease area for Pfizer. We share the concern about misuse and abuse of opioid medicines and are committed to being part of the solution to address this important public health and safety issue.”
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