12 December 2018 - SpecGx announced today that it has received a complete response letter from the U.S. FDA related to its new drug application for its investigational abuse-deterrent, immediate-release reformulation of Roxicodone (oxycodone hydrochloride) tablets, USP for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

In the letter, the Agency provided guidance regarding areas of further evaluation necessary to resubmit the application for further review and potential approval of the drug, which was designed with properties to deter intravenous and intranasal abuse under the company's 505(b)2 new drug application MNK-812.

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