News Release

Mallinckrodt's SpecGx LLC Receives FDA Complete Response Letter for Abuse-Deterrent, Immediate-Release Reformulation of Roxicodone® (Oxycodone Hydrochloride)

STAINES-UPON-THAMES, United Kingdom, Dec. 12, 2018 /PRNewswire/ -- SpecGx LLC, a subsidiary of Mallinckrodt plc (NYSE: MNK) that operates its Specialty Generics business, announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) related to its New Drug Application (NDA) 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 NDA 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.

"We are evaluating the FDA's letter and will request a meeting in the coming weeks to discuss it further," said Matt Harbaugh, President, Specialty Generics. "We continue to believe this new abuse-deterrent formulation has the potential to mitigate opioid abuse and misuse, and though we're disappointed by the FDA's decision, we will continue to pursue a pathway to try to gain approval of the drug."

The company has for years been at the forefront of preventing prescription drug diversion and abuse, and has invested millions of dollars in a multi-pronged program to address opioid abuse. In addition to abuse-deterrent technology, those efforts include the purchase and donation of nearly two million drug disposal pouches, and working with policymakers, community leaders, law enforcement and industry partners to ensure the responsible use of pain medication and preventing unused medications from ending up in the wrong hands. These efforts will continue to be supported.

Please click here for more information about these efforts.

Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. To learn more about Mallinckrodt, visit

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This release includes forward-looking statements concerning MNK-812 including expectations with regard to future regulatory actions and potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; future commercialization efforts; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.


Investor Relations
Daniel J. Speciale, CPA
Investor Relations and Strategy Officer

Rhonda Sciarra
Senior Communications Manager

Meredith Fischer
Chief Public Affairs Officer


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SOURCE Mallinckrodt plc