Acura Pharmaceuticals (ACUR) and King Pharmaceuticals (KG) have received a Complete Response Letter (CRL) from the FDA for the companies’ NDA for Acurox (oxycodone plus niacin), an abuse deterrent immediate release painkiller.

Just last week we ran this post and asked if the FDA was backed up or if a CRL was inevitable.

According to today’s press release:

The CRL raises issues regarding the potential abuse deterrent benefits of Acurox®. Acura and King are currently evaluating the FDA’s Complete Response Letter, and at this stage believe they can respond to the issues raised without conducting any additional studies. The Companies plan to meet with the FDA following submission of their response.

I guess we know what’s going on at the FDA, huh?

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