Will the FDA Approve Pfizer and Pain Therapeutics' Remoxy?

I'm going to take a wild guess and bet that until now, there have never been two drugs with the same active ingredient up for approval within one week of each other. Until now.

Pfizer (NYSE: PFE  ) and Acura Pharmaceuticals (Nasdaq: ACUR  ) announced the Food and Drug Administration approval of Oxecta on Monday, and today Pfizer and Pain Therapeutics (Nasdaq: PTIE  ) could hear from the FDA about Remoxy. The active ingredient in both drugs is oxycodone.

Why so much interest in a pain drug that's been on the market for more than 15 years? Because both Oxecta and Remoxy have abuse deterrents built in that make them harder for drug abusers to get a quick high from them. Oxecta is an immediate-release version that uses Acura's abuse-deterrent technology and Remoxy is a delayed-release formulation using DURECT's (Nasdaq: DRRX  ) technology.

Like Oxecta, this is the second attempt to gain FDA approval of Remoxy. Back in 2008, before Pfizer bough King Pharmaceuticals, the FDA turned down Remoxy. At the time, King and Pain said they didn't need to do any more clinical trials to gain approval. But the drugmakers strengthened the data package nonetheless with a trial that showed that the drug wasn't liked by patients with a history of drug abuse.

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.

My guess is for an FDA approval, but an approval is far from certain and we could even see a delay in the FDA's decision as Pfizer hinted at last month.

What's your thought? Take our Foolish poll, and if you have a strong opinion let us know why in the comment box below.

Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. Motley Fool newsletter services have recommended buying shares of Pfizer. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.


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