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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