A Less Painful FDA Decision


Not all FDA decisions have to be painful. On Friday, Johnson & Johnson (NYS: JNJ) got its extended-release version of Nucynta approved by the FDA. The immediate-release version of the pain medication has been approved since 2008, but the extended-release version was turned down in October because the agency had questions about the abuse-resistant formulation.

Despite the clear societal need, pain medications with features that attempt to make it harder to abuse the drug have had a hard time getting past the FDA. Pfizer (NYS: PFE) , Pain Therapeutics (NAS: PTIE) , and DURECT (NAS: DRRX) had a similar experience earlier this year when the agency turned down their abuse-resistant pain medication, Remoxy.

For Nucynta, the problem seemed to have stemmed from the company using a regular formula in the clinical trials but switching to the abuse-resistant formulation for approval. A little paperwork later and Johnson & Johnson has cleared up the mess and can market the extended-release formula.

I doubt that'll give Remoxy's developers much confidence of a quick resubmission. For Remoxy, the FDA wants to know about apparent inconsistencies in the manufacturing of the drug, but the companies aren't sure whether it's a problem with the manufacturing or just the test that's checking to make sure the manufacturing is correct.

Johnson & Johnson's extended-release drug -- which will go by the not-so-original name, Nucynta ER -- should expand Johnson & Johnson's potential market to patients with chronic pain that need continuous relief. It'll have to compete with Purdue Pharma's abuse-deterrent extended-release oxycodone, but at least Johnson & Johnson won't have to deal with Remoxy when it launches the drug.

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At the time thisarticle was published Fool contributorBrian Orelliholds no position in any company mentioned.Click hereto see his holdings and a short bio. The Motley Fool owns shares of Johnson & Johnson.Motley Fool newsletter serviceshave recommended buying shares of Johnson & Johnson and Pfizer, as well as creating a diagonal call position in Johnson & Johnson. Try any of our Foolish newsletter servicesfree for 30 days. We Fools may not all hold the same opinions, but we all believe thatconsidering a diverse range of insightsmakes us better investors. The Motley Fool has adisclosure policy.

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